Postoperative Pancreatic FistulaPANDREASNCT06141044
Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy
A study testing Avoid surgical drainage in people with Postoperative Pancreatic Fistula and Distal Pancreatectomy, run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial summary
Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes of hospital length of stay and healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pancreatic Fistula, Distal Pancreatectomy, Drainage
- What is being tested?
- Avoid surgical drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (over 18 years of age) undergoing elective distal pancreatectomy surgery for any indication, with or without splenectomy, minimally invasive or open. It is not necessary to integrate gender perspective as it is not relevant and there is no influence on the results of POPF or morbidity.
- Signed informed consent was obtained from each of the patients included in the study.
Who cannot join
- Patients undergoing distal pancreatectomy as a secondary procedure
- Additional liver, gastric or colonic resection
- Pregnancy
- Participation in another study
- History of previous surgery involving the pancreas
- Patients with American Society of Anaesthesiologists classification 4
- Arterial resection other than the splenic artery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PANDREAS. Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy: a Multicentre Clinical Trial
Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes of hospital length of stay and healthcare costs. Numerous surgical techniques have been tested to reduce its incidence without success, so the current standard for the management of POPF, and the avoidance of associated complications, is intraoperative drain placement. However, surgically placed drains are not without risk. In recent years many studies, mostly retrospective, have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity. These studies suggest that patients may benefit from not having a drain placed. This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open. The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy.
Read the detailed description
A prospective, randomised, multicentre, multicentre, randomised non-inferiority study is designed. The aim is to study whether patients who undergo distal pancreatectomy can benefit from the non-placement of a drain in terms of clinically relevant postoperative pancreatic fistula and Clavien-Dindo morbidity greater than or equal to 3.
Information will be collected for all patients undergoing distal pancreatectomy surgery at the collaborating centres who, upon invitation, voluntarily agree to participate in the study. Those who have agreed to participate, given written consent and meet the inclusion criteria and none of the exclusion criteria will be randomly assigned to one of the following treatment groups:
- Control group: patients who, after distal pancreatectomy, in whom abdominal drainage is placed.
- Intervention group: patients who, after distal pancreatectomy, will be omitted the placement of an abdominal drain.
Following the postoperative pancreatic fistula score according to the DISPAIR criteria, patients included in the present study will be stratified according to the preoperative risk of postoperative pancreatic fistula into: extreme, high, moderate and low.
The standards of surgical technique to be followed in both open and minimally invasive distal pancreatectomy were agreed by consensus.
Each patient will be followed up for 6 months from the time of randomisation (day of surgery).Those responsible for the recruitment and selection of patients for inclusion in the research project belong to the Multidisciplinary Committee of Hepatobiliary and Pancreatic Surgery of each centre. Surgical intervention, postoperative management and perioperative morbidity will be evaluated by the surgeon responsible for the patient. A patient recruitment period of 2 years is estimated. After a follow-up period of 6 months, an analysis of postoperative pancreatic fistula rate, perioperative morbidity, biochemical parameters and quality of life will be performed.
- Being tested
- Avoid surgical drainage
- Keywords
- Postoperative pancreatic fistula, Distal Pancreatectomy, Intraoperative Drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avoid surgical drainageProcedure or surgery
Patients who undergo distal pancreatectomy, avoid placing a drain.
| Study group | Role | What they receive |
|---|---|---|
| Drainage | No intervention | Patients undergoing distal pancreatectomy with surgical drainage. |
| No drainage | Experimental | Patients undergoing distal pancreatectomy without surgical drainage. Receives: Procedure: Avoid surgical drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically relevant postoperative pancreatic fistula
The investigators define a clinically relevant pancreatic fistula following the 2016 update of the International Study Group (ISGPS) definition. According to this, a Clinically Relevant Postoperative Pancreatic Fistula refers to a grade B or C. Grade B requires a change in the postoperative management; drains are either left in place >3 weeks or repositioned through endoscopic or percutaneous procedures. Grade C postoperative pancreatic fistula refers to those postoperative pancreatic fistula that require reoperation or lead to single or multiple organ failure and/or mortality attributable to the pancreatic fistula.
Measured: From first postoperative day until day 30 after surgery
Secondary outcomes (23)
Clavien-Dindo morbidity greater than or equal to 3.
To evaluate postoperative morbidity (Clavien-Dindo 3 or higher complications) in patients who undergo distal pancreatectomy. Comparing between the two groups of patients if there are any differences due to the presence or absence of a drainage.
According to the Clavien-Dindo classification:
3 - Requiring surgical, endoscopic or radiological intervention 3a-Intervention under regional/local anesthesia 3b- Intervention under general anesthesia 4 -Life-threatening complication requiring intensive care/intensive care unit management 4a- Single organ dysfunction 4b- Multi-organ dysfunction 5 - Patient demise
Measured: From first postoperative day until the ninth month after surgery
Reoperation.
To determine the rates of reoperation 90 days after distal pancreatectomy
Measured: From first postoperative day until day 90 after surgery
Percutaneous drainage.
To determine the rates of percutaneous drainage 90 days after distal pancreatectomy. The need for a percutaneous drainage procedure, using an endoscopic or radiological approach, for the treatment of postoperative pancreatic fistula.
Measured: From first postoperative day until day 90 after surgery
Abdominal collections
To determine the rate of abdominal collections 90 days after distal pancreatectomy. The investigators define an abdominal collection as a presence of liquid in the abdomen that cause symptoms in the patient, such as fever, and that may require less invasive therapeutic agents and treatment or percutaneous, endoscopic or angiographic interventional procedures.
Measured: From first postoperative day until day 90 after surgery
Surgical wound infection.
To determine the rates of surgical site infection after distal pancreatectomy. Surgical site infection (SSI) is classified according to the Center for Disease Control and Prevention definition.
Measured: From first postoperative day until day 90 after surgery
Delayed gastric emptying.
To determine rates of delayed gastric emptying after distal pancreatectomy. Delayed gastric emptying represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A, B, and C) are defined based on the impact on the clinical course and on postoperative management, according to the definition by the International Study Group of Pancreatic Surgery (ISGPS).
Measured: From first postoperative day until day 90 after surgery
Postoperative bleeding.
According to the definition by the International Study Group of Pancreatic Surgery (ISGPS), postpancreatectomy bleeding is defined by 3 parameters: onset, location, and severity. The onset is either early (< or =24 hours after the end of the index operation) or late (>24 hours). The location is either intraluminal or extraluminal. The severity of bleeding may be either mild or severe.
Three different grades of postpancreatectomy hemorrhage (grades A, B, and C) are defined according to the time of onset, site of bleeding, severity, and clinical impact.
Measured: From first postoperative day until day 90 after surgery
Blood transfusion.
To determine rates of blood transfusion, measured in red blood cell concentrates after distal pancreatectomy.
Measured: From first postoperative day until day 90 after surgery
Length of hospital stay
To determine rates of length of hospital stay after distal pancreatectomy. The length of hospital stay will be measured in days.
Measured: From first postoperative day until day 90 after surgery
In-hospital mortality.
To determine rates of in-hospital mortality after distal pancreatectomy. The investigators will collet how many patients die during the hospitalization after surgery.
Measured: From first postoperative day after surgery.
Intensive care admission.
To determine rates of intensive care admission 90 days after distal pancreatectomy. The investigators will measure how many patients need an intensive care admission and how long after surgery.
Measured: From first postoperative day until day 90 after surgery
Mortality.
To determine rates of mortality 90 days after distal pancreatectomy
Measured: From first postoperative day until day 90 after surgery
Readmission.
To determine rates of readmission 90 days after distal pancreatectomy. The investigators will collect how many patients, after surgery, needed for a readmission.
Measured: From first postoperative day until day 90 after surgery
To study the role of serum amylase in the development of postoperative pancreatic fistula.
The relevance of some biochemical markers that, in an early stage, can predict the development of postoperative pancreatic fistula has recently been highlighted.
The serum amylase will be measured in U/L.
Measured: From first postoperative day until the fifth day after surgery
To study the role of amylase production in drainage in the development of postoperative pancreatic fistula.
These data will be analysed on the first, third and fifth postoperative day. Amylase concentration in surgical drainage: The amylase concentration in surgical drainage will be measured on postoperative days 1, 3 and 5 to assess the early diagnostic ability of postoperative pancreatic fistula, of a concentration greater than 2000U/L.
Drainage fluid amylase production, U/day (the product of the drainage fluid amylase value U/L and the amount of drainage, mL/day) will also be measured.
Measured: From first postoperative day until the fifth day after surgery
To study the role of biochemical parameters C-Reactive Protein in the development of postoperative pancreatic fistula.
C-reactive protein concentration will be performed on postoperative days 1, 3 and 5 to assess the early diagnostic capability of POPF of a CRP concentration greater than 100 mg/L.
Measured: From first postoperative day until the fifth day after surgery
To study the role of Neutrophil-Lymphocyte Ratio (NLR) in the development of postoperative pancreatic fistula.
The neutrophil/lymphocyte ratio has been published as a biochemical marker for the development of postoperative pancreatic fistula in duodenopancreatectomy.
The investigators propose its analysis as a secondary objective, in order to determine its role as an early biochemical marker of fistula after distal pancreatectomy.
Haemogram for calculation of serum leukocyte count will be performed on postoperative days 1, 3 and 5 to assess the early diagnostic capability of postoperative pancreatic fistula of a NLR greater than 8.5 mg/dl on these postoperative days.
Measured: From first postoperative day until the fifth day after surgery
To identify subgroups of patients according to their risk for postoperative pancreatic fistula
In order to obtain the best evidence, it is proposed not only to analyse differences in morbidity, but also to stratify patients by risk of postoperative pancreatic fistula after distal pancreatectomy, as it is unclear whether omitting routine drainage in subgroups at high risk of postoperative pancreatic fistula could increase the risk of complications.To stratify patients according to the risk of postoperative pancreatic fistula, the DISPAIR score will be used which takes into account three variables: transection site (neck versus body/tail), pancreatic thickness at the transection site and diabetes. These variables have been previously studied as risk factors associated with postoperative pancreatic fistula.
Measured: From first postoperative day until the fifth day after surgery
To analyse the quality of life of patients undergoing distal pancreatectomy
To analyse the quality of life of patients undergoing distal pancreatectomy. Variations in patients' quality of life will be measured using the official European Organization for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 (generic quality of life questionnaire for cancer patients) and QLQ-PAN26 (specific quality of life questionnaire for pancreatic cancer patients). Although these questionnaires were developed for cancer patients and pancreatic cancer patients, they are widely used to assess postoperative quality of life after pancreatic surgery.
Measured: From first postoperative day until the ninth month after surgery
To examine the relevance of the neutrophil-lymphocyte ratio in the exclusion of postoperative pancreatic fistula after distal pancreatectomy.
To examine the relevance of the neutrophil-lymphocyte ratio in the exclusion of postoperative pancreatic fistula after distal pancreatectomy.
Measured: From first postoperative day until the fifth day after surgery
To compare the quality of life of patients who undergo distal pancreatectomy according to the placement or non-placement of an intraoperative drain
To compare the quality of life of patients who undergo distal pancreatectomy according to the placement or non-placement of an intraoperative drain.
Variations in patients' quality of life will be measured using the official European Organization for Research and Treatment of Cancer (EORTC). Although this questionnaires were developed for cancer patients and pancreatic cancer patients, they are widely used to assess postoperative quality of life after pancreatic surgery.
Measured: From first postoperative day until the ninth month after surgery
To compare the quality of life of patients who undergo distal pancreatectomy according to the placement or non-placement of an intraoperative drain
Variations in patients' quality of life will be measured using the QLQ-C30 (generic quality of life questionnaire for cancer patients).Although this questionnaires were developed for cancer patients and pancreatic cancer patients, they are widely used to assess postoperative quality of life after pancreatic surgery.
Measured: From first postoperative day until ninth month after surgery
To compare the quality of life of patients who undergo distal pancreatectomy according to the placement or non-placement of an intraoperative drain
Variations in patients' quality of life will be measured using the QLQ-PAN26 (specific quality of life questionnaire for pancreatic cancer patients).Although this questionnaires were developed for cancer patients and pancreatic cancer patients, they are widely used to assess postoperative quality of life after pancreatic surgery.
Measured: From first postoperative day until ninth month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pancreatic FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National, randomised, prospective, non-inferiority, multicentre clinical trial.To comparatively evaluate the rate of postoperative pancreatic fistula in patients undergoing distal pancreatectomy in one group with and one group without surgical drainage.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Rotellar, MD, PhD, Study director, Clinica Universidad de Navarra, Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141044
- Sponsor's protocol ID
- PANDREAS21101995
- Acronym
- PANDREAS
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Databases with anonymized IPD will be shared at the end of the study.
Publications
Lillemoe KD, Kaushal S, Cameron JL, Sohn TA, Pitt HA, Yeo CJ. Distal pancreatectomy: indications and outcomes in 235 patients. Ann Surg. 1999 May;229(5):693-8; discussion 698-700. doi: 10.1097/00000658-199905000-00012.
PubMed 10235528Balcom JH 4th, Rattner DW, Warshaw AL, Chang Y, Fernandez-del Castillo C. Ten-year experience with 733 pancreatic resections: changing indications, older patients, and decreasing length of hospitalization. Arch Surg. 2001 Apr;136(4):391-8. doi: 10.1001/archsurg.136.4.391.
PubMed 11296108Kleeff J, Diener MK, Z'graggen K, Hinz U, Wagner M, Bachmann J, Zehetner J, Muller MW, Friess H, Buchler MW. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2007 Apr;245(4):573-82. doi: 10.1097/01.sla.0000251438.43135.fb.
PubMed 17414606Sledzianowski JF, Duffas JP, Muscari F, Suc B, Fourtanier F. Risk factors for mortality and intra-abdominal morbidity after distal pancreatectomy. Surgery. 2005 Feb;137(2):180-5. doi: 10.1016/j.surg.2004.06.063.
PubMed 15674199Nathan H, Cameron JL, Goodwin CR, Seth AK, Edil BH, Wolfgang CL, Pawlik TM, Schulick RD, Choti MA. Risk factors for pancreatic leak after distal pancreatectomy. Ann Surg. 2009 Aug;250(2):277-81. doi: 10.1097/SLA.0b013e3181ae34be.
PubMed 19638926Pannegeon V, Pessaux P, Sauvanet A, Vullierme MP, Kianmanesh R, Belghiti J. Pancreatic fistula after distal pancreatectomy: predictive risk factors and value of conservative treatment. Arch Surg. 2006 Nov;141(11):1071-6; discussion 1076. doi: 10.1001/archsurg.141.11.1071.
PubMed 17116799Knaebel HP, Diener MK, Wente MN, Buchler MW, Seiler CM. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg. 2005 May;92(5):539-46. doi: 10.1002/bjs.5000.
PubMed 15852419Karabicak I, Satoi S, Yanagimoto H, Yamamoto T, Yamaki S, Kosaka H, Hirooka S, Kotsuka M, Michiura T, Inoue K, Matsui Y, Kon M. Comparison of surgical outcomes of three different stump closure techniques during distal pancreatectomy. Pancreatology. 2017 May-Jun;17(3):497-503. doi: 10.1016/j.pan.2017.04.005. Epub 2017 Apr 8.
PubMed 28411019Ecker BL, McMillan MT, Allegrini V, Bassi C, Beane JD, Beckman RM, Behrman SW, Dickson EJ, Callery MP, Christein JD, Drebin JA, Hollis RH, House MG, Jamieson NB, Javed AA, Kent TS, Kluger MD, Kowalsky SJ, Maggino L, Malleo G, Valero V 3rd, Velu LKP, Watkins AA, Wolfgang CL, Zureikat AH, Vollmer CM Jr. Risk Factors and Mitigation Strategies for Pancreatic Fistula After Distal Pancreatectomy: Analysis of 2026 Resections From the International, Multi-institutional Distal Pancreatectomy Study Group. Ann Surg. 2019 Jan;269(1):143-149. doi: 10.1097/SLA.0000000000002491.
PubMed 28857813Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88.
PubMed 20622661Conlon KC, Labow D, Leung D, Smith A, Jarnagin W, Coit DG, Merchant N, Brennan MF. Prospective randomized clinical trial of the value of intraperitoneal drainage after pancreatic resection. Ann Surg. 2001 Oct;234(4):487-93; discussion 493-4. doi: 10.1097/00000658-200110000-00008.
PubMed 11573042Mangieri CW, Kuncewitch M, Fowler B, Erali RA, Moaven O, Shen P, Clark CJ. Surgical drain placement in distal pancreatectomy is associated with an increased incidence of postoperative pancreatic fistula and higher readmission rates. J Surg Oncol. 2020 Sep;122(4):723-728. doi: 10.1002/jso.26072. Epub 2020 Jul 2.
PubMed 32614999Paulus EM, Zarzaur BL, Behrman SW. Routine peritoneal drainage of the surgical bed after elective distal pancreatectomy: is it necessary? Am J Surg. 2012 Oct;204(4):422-7. doi: 10.1016/j.amjsurg.2012.02.005. Epub 2012 May 10.
PubMed 22579230Behrman SW, Zarzaur BL, Parmar A, Riall TS, Hall BL, Pitt HA. Routine drainage of the operative bed following elective distal pancreatectomy does not reduce the occurrence of complications. J Gastrointest Surg. 2015 Jan;19(1):72-9; discussion 79. doi: 10.1007/s11605-014-2608-z. Epub 2014 Aug 13.
PubMed 25115324Correa-Gallego C, Brennan MF, D'angelica M, Fong Y, Dematteo RP, Kingham TP, Jarnagin WR, Allen PJ. Operative drainage following pancreatic resection: analysis of 1122 patients resected over 5 years at a single institution. Ann Surg. 2013 Dec;258(6):1051-8. doi: 10.1097/SLA.0b013e3182813806.
PubMed 23360918
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PANDREAS. Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy: a Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT06141044
- Acronym / sponsor ID
- PANDREAS / PANDREAS21101995
- Keywords
- Postoperative pancreatic fistula, Distal Pancreatectomy, Intraoperative Drainage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes of hospital length of stay and healthcare costs. Numerous surgical techniques have been tested to reduce its incidence without success, so the current standard for the management of POPF, and the avoidance of associated complications, is intraoperative drain placement. However, surgically placed drains are not without risk. In recent years many studies, mostly retrospective, have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity. These studies suggest that patients may benefit from not having a drain placed. This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open. The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy.
Detailed description
A prospective, randomised, multicentre, multicentre, randomised non-inferiority study is designed. The aim is to study whether patients who undergo distal pancreatectomy can benefit from the non-placement of a drain in terms of clinically relevant postoperative pancreatic fistula and Clavien-Dindo morbidity greater than or equal to 3.
Information will be collected for all patients undergoing distal pancreatectomy surgery at the collaborating centres who, upon invitation, voluntarily agree to participate in the study. Those who have agreed to participate, given written consent and meet the inclusion criteria and none of the exclusion criteria will be randomly assigned to one of the following treatment groups:
- Control group: patients who, after distal pancreatectomy, in whom abdominal drainage is placed.
- Intervention group: patients who, after distal pancreatectomy, will be omitted the placement of an abdominal drain.
Following the postoperative pancreatic fistula score according to the DISPAIR criteria, patients included in the present study will be stratified according to the preoperative risk of postoperative pancreatic fistula into: extreme, high, moderate and low.
The standards of surgical technique to be followed in both open and minimally invasive distal pancreatectomy were agreed by consensus.
Each patient will be followed up for 6 months from the time of randomisation (day of surgery).Those responsible for the recruitment and selection of patients for inclusion in the research project belong to the Multidisciplinary Committee of Hepatobiliary and Pancreatic Surgery of each centre. Surgical intervention, postoperative management and perioperative morbidity will be evaluated by the surgeon responsible for the patient. A patient recruitment period of 2 years is estimated. After a follow-up period of 6 months, an analysis of postoperative pancreatic fistula rate, perioperative morbidity, biochemical parameters and quality of life will be performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- National, randomised, prospective, non-inferiority, multicentre clinical trial.To comparatively evaluate the rate of postoperative pancreatic fistula in patients undergoing distal pancreatectomy in one group with and one group without surgical drainage.
| Arm | Type | Receives |
|---|---|---|
| Drainage | No intervention | –Patients undergoing distal pancreatectomy with surgical drainage. |
| No drainage | Experimental | Procedure: Avoid surgical drainagePatients undergoing distal pancreatectomy without surgical drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (over 18 years of age) undergoing elective distal pancreatectomy surgery for any indication, with or without splenectomy, minimally invasive or open. It is not necessary to integrate gender perspective as it is not relevant and there is no influence on the results of POPF or morbidity.
- Signed informed consent was obtained from each of the patients included in the study.
Key exclusion criteria (7 listed)
- Patients undergoing distal pancreatectomy as a secondary procedure
- Additional liver, gastric or colonic resection
- Pregnancy
- Participation in another study
- History of previous surgery involving the pancreas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avoid surgical drainagePatients who undergo distal pancreatectomy, avoid placing a drain. | Procedure or surgery | No drainage |
Primary outcome
Clinically relevant postoperative pancreatic fistula
Time frame: From first postoperative day until day 30 after surgery
The investigators define a clinically relevant pancreatic fistula following the 2016 update of the International Study Group (ISGPS) definition. According to this, a Clinically Relevant Postoperative Pancreatic Fistula refers to a grade B or C. Grade B requires a change in the postoperative management; drains are either left in place >3 weeks or repositioned through endoscopic or percutaneous procedures. Grade C postoperative pancreatic fistula refers to those postoperative pancreatic fistula that require reoperation or lead to single or multiple organ failure and/or mortality attributable to the pancreatic fistula.
23 secondary outcomes
Clavien-Dindo morbidity greater than or equal to 3.
Time frame: From first postoperative day until the ninth month after surgery
Reoperation.
Time frame: From first postoperative day until day 90 after surgery
Percutaneous drainage.
Time frame: From first postoperative day until day 90 after surgery
Abdominal collections
Time frame: From first postoperative day until day 90 after surgery
Surgical wound infection.
Time frame: From first postoperative day until day 90 after surgery
Delayed gastric emptying.
Time frame: From first postoperative day until day 90 after surgery
Postoperative bleeding.
Time frame: From first postoperative day until day 90 after surgery
Blood transfusion.
Time frame: From first postoperative day until day 90 after surgery
Length of hospital stay
Time frame: From first postoperative day until day 90 after surgery
In-hospital mortality.
Time frame: From first postoperative day after surgery.
Intensive care admission.
Time frame: From first postoperative day until day 90 after surgery
Mortality.
Time frame: From first postoperative day until day 90 after surgery
Readmission.
Time frame: From first postoperative day until day 90 after surgery
To study the role of serum amylase in the development of postoperative pancreatic fistula.
Time frame: From first postoperative day until the fifth day after surgery
To study the role of amylase production in drainage in the development of postoperative pancreatic fistula.
Time frame: From first postoperative day until the fifth day after surgery
To study the role of biochemical parameters C-Reactive Protein in the development of postoperative pancreatic fistula.
Time frame: From first postoperative day until the fifth day after surgery
To study the role of Neutrophil-Lymphocyte Ratio (NLR) in the development of postoperative pancreatic fistula.
Time frame: From first postoperative day until the fifth day after surgery
To identify subgroups of patients according to their risk for postoperative pancreatic fistula
Time frame: From first postoperative day until the fifth day after surgery
To analyse the quality of life of patients undergoing distal pancreatectomy
Time frame: From first postoperative day until the ninth month after surgery
To examine the relevance of the neutrophil-lymphocyte ratio in the exclusion of postoperative pancreatic fistula after distal pancreatectomy.
Time frame: From first postoperative day until the fifth day after surgery
To compare the quality of life of patients who undergo distal pancreatectomy according to the placement or non-placement of an intraoperative drain
Time frame: From first postoperative day until the ninth month after surgery
To compare the quality of life of patients who undergo distal pancreatectomy according to the placement or non-placement of an intraoperative drain
Time frame: From first postoperative day until ninth month after surgery
To compare the quality of life of patients who undergo distal pancreatectomy according to the placement or non-placement of an intraoperative drain
Time frame: From first postoperative day until ninth month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 10235528Lillemoe KD, Kaushal S, Cameron JL, Sohn TA, Pitt HA, Yeo CJ. Distal pancreatectomy: indications and outcomes in 235 patients. Ann Surg. 1999 May;229(5):693-8; discussion 698-700. doi: 10.1097/00000658-199905000-00012.
- Background: PubMed 11296108Balcom JH 4th, Rattner DW, Warshaw AL, Chang Y, Fernandez-del Castillo C. Ten-year experience with 733 pancreatic resections: changing indications, older patients, and decreasing length of hospitalization. Arch Surg. 2001 Apr;136(4):391-8. doi: 10.1001/archsurg.136.4.391.
- Background: PubMed 17414606Kleeff J, Diener MK, Z'graggen K, Hinz U, Wagner M, Bachmann J, Zehetner J, Muller MW, Friess H, Buchler MW. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2007 Apr;245(4):573-82. doi: 10.1097/01.sla.0000251438.43135.fb.
- Background: PubMed 15674199Sledzianowski JF, Duffas JP, Muscari F, Suc B, Fourtanier F. Risk factors for mortality and intra-abdominal morbidity after distal pancreatectomy. Surgery. 2005 Feb;137(2):180-5. doi: 10.1016/j.surg.2004.06.063.
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- Individual participant dataSharing planned: Yes. Databases with anonymized IPD will be shared at the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando Rotellar, MD, PhD study director
Clinica Universidad de Navarra, Universidad de Navarra
Questions about this trial
What is this clinical trial studying?
A study testing Avoid surgical drainage in people with Postoperative Pancreatic Fistula and Distal Pancreatectomy, run by Clinica Universidad de Navarra, Universidad de Navarra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando Rotellar, MD, PhD (948255400 ext. 4729, frotellar@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically relevant postoperative pancreatic fistula (time frame: From first postoperative day until day 30 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06141044, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.