Pancreatic FistulaPREPNCT03212196
Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant
A study testing Pancreaticogastrostomy with external drain and Pancreaticojejunostomy with transanastomotic drain in people with Pancreatic Fistula, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
This trial will investigate what surgical technique between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains is associated with the lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk pancreatic remnants. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Pancreaticogastrostomy with external drain and Pancreaticojejunostomy with transanastomotic drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2017to 10 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the patients undergoing pancreaticoduodenectomy (only Whipple or Traverso) for all kind of pancreatic disease (benign, malignant or premalignant).
- Patients able to give their informed consent
Who cannot join
- Informed consent withdrawal
- Impossibility to undergo surgery for any reason
- Use of glues or biological matrices to protect the anastomosis
- Fistula Risk Score < 7
- Post-operative octreotide analogues administration (only prophylactic use, therapeutic use allowed)
- Wrong randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant: a Risk-adjusted Randomized Controlled Trial
This trial will investigate what surgical technique between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains is associated with the lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk pancreatic remnants.
Read the detailed description
Pancreatic fistula is the major determinant of outcome after pancreaticoduodenectomy. Several strategies to reduce the burden of this complication have been proposed in the last decade. A definite answer about what is the best technique to approach a high-risk pancreatic stump is still needed. Both pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains have been proposed in this setting, but often studies do not provide a reliable risk stratification and result are extremely variable.
The aim of this trial is to evaluate what surgical technique, between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains, is associated with the lowest rate of pancreatic fistula in case of high-risk pancreatic remnants. Risk stratification will be provided through the Fistula Risk Score, a clinical risk score that has been extensively validated.
- Conditions
- Pancreatic Fistula
- Being tested
- Pancreaticogastrostomy with external drain, Pancreaticojejunostomy with transanastomotic drain
- Keywords
- Pancreaticoduodenectomy, Pancreaticogastrostomy, Pancreaticojejunostomy, Stent, Transanastomotic drain
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaticogastrostomy with external drainProcedure or surgery
Pancreatico-enteric anastomosis is provided according to the "Bassi technique", pancreatic remnant is pushed into the gastric cavity through a posterior gastrotomy. An externalized drain is placed into the main pancreatic duct.
Pancreaticojejunostomy with transanastomotic drainProcedure or surgery
Pancreatico-enteric anastomosis is provided through a double-layer, duct-to-mucosa anastomosis with a transanastomotic externalized drain.
| Study group | Role | What they receive |
|---|---|---|
| Pancreaticogastrostomy | Active comparator | Pancreaticogastrostomy with external drain Receives: Procedure: Pancreaticogastrostomy with external drain |
| Pancreaticojejunostomy | Active comparator | Pancreaticojejunostomy with transanastomotic drain Receives: Procedure: Pancreaticojejunostomy with transanastomotic drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pancreatic Fistula (POPF)
Presence of Amylase > 3 times the upper limit of normal in surgical drains at or by post-operative day 3 (POD) determining a clinically relevant change in patient's management
Measured: 30 days post-operative
Secondary outcomes (21)
POPF severity
POPF grade B and grade C rates
Measured: 30 days post-operative
Length of Hospital Stay
calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission
Measured: 1 year
Mortality
Death related to surgical morbidity
Measured: 90 days
Post-Pancreatectomy Hemorrhage
As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Measured: 90 days
Delayed Gastric Emptying
As defined by ISGPS, grade A, B and C rates
Measured: 90 days
Biliary fistula
Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out
Measured: 90 days
Gastrojejunal/Duodenojejunal fistula
Fistula from gastro/duodenojejunostomy
Measured: 90 days
Abdominal abscess
Collection >5cm in size, containing gas bubbles, determining systemic signs of infection
Measured: 90 days
Acute pancreatitis
Altered serum amylase count on POD 0 or POD 1
Measured: 1 day post index surgery
Wound infection
Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention
Measured: 90 days
Blood transfusions
Need and number of packed red blood cells transfused
Measured: 90 days
Myocardial infarction
Myocardial necrosis
Measured: 90 days
Acute Kidney Failure
Abrupt change in serum creatinine >1.5 baseline value
Measured: 90 days
Pulmonary Embolism
Blood clots in the pulmonary arterial system
Measured: 90 days
Pneumonia
Bacterial infection of the lungs
Measured: 90 days
Respiratory insufficiency
Need for re-intubation
Measured: 90 days
Urinary Tract Infection
Bacterial infection of the urinary tract
Measured: 90 days
Cerebrovascular accidents
Stroke, hemorrhage, brain death
Measured: 90 days
Reoperation
Need for new surgery due to severe morbidity
Measured: 90 days
Readmission
New admission within 30-days of discharge from hospital
Measured: 30 days after hospital discharge
Time-to-adjuvant therapy
Time form index operation to the beginning of adjuvant treatment (only for malignancy)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start12 Jun 2017
- Primary completion10 Jun 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio Bassi, MD, Principal investigator, Università degli studi di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212196
- Sponsor's protocol ID
- PREP 1041CESC
- Acronym
- PREP
- Status last verified
- Sep 2019
- First submitted
- 9 Nov 2016
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared with other researchers
Publications
McMillan MT, Ecker BL, Behrman SW, Callery MP, Christein JD, Drebin JA, Fraker DL, Kent TS, Lee MK, Roses RE, Sprys MH, Vollmer CM Jr. Externalized Stents for Pancreatoduodenectomy Provide Value Only in High-Risk Scenarios. J Gastrointest Surg. 2016 Dec;20(12):2052-2062. doi: 10.1007/s11605-016-3289-6. Epub 2016 Oct 11.
PubMed 27730401Bassi 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 20622661Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.
PubMed 23122535Hallet J, Zih FS, Deobald RG, Scheer AS, Law CH, Coburn NG, Karanicolas PJ. The impact of pancreaticojejunostomy versus pancreaticogastrostomy reconstruction on pancreatic fistula after pancreaticoduodenectomy: meta-analysis of randomized controlled trials. HPB (Oxford). 2015 Feb;17(2):113-22. doi: 10.1111/hpb.12299. Epub 2014 Jul 7.
PubMed 25040921Wang SE, Chen SC, Shyr BU, Shyr YM. Comparison of Modified Blumgart pancreaticojejunostomy and pancreaticogastrostomy after pancreaticoduodenectomy. HPB (Oxford). 2016 Mar;18(3):229-35. doi: 10.1016/j.hpb.2015.09.007. Epub 2015 Nov 17.
PubMed 27017162Andrianello S, Marchegiani G, Malleo G, Masini G, Balduzzi A, Paiella S, Esposito A, Landoni L, Casetti L, Tuveri M, Salvia R, Bassi C. Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis: A Single-Center, Phase 3, Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):313-321. doi: 10.1001/jamasurg.2019.6035.
PubMed 32101272
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant: a Risk-adjusted Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03212196
- Acronym / sponsor ID
- PREP / PREP 1041CESC
- Conditions
- Pancreatic Fistula
- Keywords
- Pancreaticoduodenectomy, Pancreaticogastrostomy, Pancreaticojejunostomy, Stent, Transanastomotic drain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 11 Jul 2017 (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.
This trial will investigate what surgical technique between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains is associated with the lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk pancreatic remnants.
Detailed description
Pancreatic fistula is the major determinant of outcome after pancreaticoduodenectomy. Several strategies to reduce the burden of this complication have been proposed in the last decade. A definite answer about what is the best technique to approach a high-risk pancreatic stump is still needed. Both pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains have been proposed in this setting, but often studies do not provide a reliable risk stratification and result are extremely variable.
The aim of this trial is to evaluate what surgical technique, between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains, is associated with the lowest rate of pancreatic fistula in case of high-risk pancreatic remnants. Risk stratification will be provided through the Fistula Risk Score, a clinical risk score that has been extensively validated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreaticogastrostomy | Active comparator | Procedure: Pancreaticogastrostomy with external drainPancreaticogastrostomy with external drain |
| Pancreaticojejunostomy | Active comparator | Procedure: Pancreaticojejunostomy with transanastomotic drainPancreaticojejunostomy with transanastomotic drain |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All the patients undergoing pancreaticoduodenectomy (only Whipple or Traverso) for all kind of pancreatic disease (benign, malignant or premalignant).
- Patients able to give their informed consent
Key exclusion criteria (6 listed)
- Informed consent withdrawal
- Impossibility to undergo surgery for any reason
- Use of glues or biological matrices to protect the anastomosis
- Fistula Risk Score < 7
- Post-operative octreotide analogues administration (only prophylactic use, therapeutic use allowed)
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 |
|---|---|---|
| Pancreaticogastrostomy with external drainPancreatico-enteric anastomosis is provided according to the "Bassi technique", pancreatic remnant is pushed into the gastric cavity through a posterior gastrotomy. An externalized drain is placed into the main pancreatic duct. | Procedure or surgery | Pancreaticogastrostomy |
| Pancreaticojejunostomy with transanastomotic drainPancreatico-enteric anastomosis is provided through a double-layer, duct-to-mucosa anastomosis with a transanastomotic externalized drain. | Procedure or surgery | Pancreaticojejunostomy |
Primary outcome
Post-operative Pancreatic Fistula (POPF)
Time frame: 30 days post-operative
Presence of Amylase > 3 times the upper limit of normal in surgical drains at or by post-operative day 3 (POD) determining a clinically relevant change in patient's management
21 secondary outcomes
POPF severity
Time frame: 30 days post-operative
Length of Hospital Stay
Time frame: 1 year
Mortality
Time frame: 90 days
Post-Pancreatectomy Hemorrhage
Time frame: 90 days
Delayed Gastric Emptying
Time frame: 90 days
Biliary fistula
Time frame: 90 days
Gastrojejunal/Duodenojejunal fistula
Time frame: 90 days
Abdominal abscess
Time frame: 90 days
Acute pancreatitis
Time frame: 1 day post index surgery
Wound infection
Time frame: 90 days
Blood transfusions
Time frame: 90 days
Myocardial infarction
Time frame: 90 days
Acute Kidney Failure
Time frame: 90 days
Pulmonary Embolism
Time frame: 90 days
Pneumonia
Time frame: 90 days
Respiratory insufficiency
Time frame: 90 days
Urinary Tract Infection
Time frame: 90 days
Cerebrovascular accidents
Time frame: 90 days
Reoperation
Time frame: 90 days
Readmission
Time frame: 30 days after hospital discharge
Time-to-adjuvant therapy
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Background: PubMed 27730401McMillan MT, Ecker BL, Behrman SW, Callery MP, Christein JD, Drebin JA, Fraker DL, Kent TS, Lee MK, Roses RE, Sprys MH, Vollmer CM Jr. Externalized Stents for Pancreatoduodenectomy Provide Value Only in High-Risk Scenarios. J Gastrointest Surg. 2016 Dec;20(12):2052-2062. doi: 10.1007/s11605-016-3289-6. Epub 2016 Oct 11.
- Background: PubMed 20622661Bassi 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.
- Background: PubMed 23122535Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.
- Background: PubMed 25040921Hallet J, Zih FS, Deobald RG, Scheer AS, Law CH, Coburn NG, Karanicolas PJ. The impact of pancreaticojejunostomy versus pancreaticogastrostomy reconstruction on pancreatic fistula after pancreaticoduodenectomy: meta-analysis of randomized controlled trials. HPB (Oxford). 2015 Feb;17(2):113-22. doi: 10.1111/hpb.12299. Epub 2014 Jul 7.
- Background: PubMed 27017162Wang SE, Chen SC, Shyr BU, Shyr YM. Comparison of Modified Blumgart pancreaticojejunostomy and pancreaticogastrostomy after pancreaticoduodenectomy. HPB (Oxford). 2016 Mar;18(3):229-35. doi: 10.1016/j.hpb.2015.09.007. Epub 2015 Nov 17.
- Derived from this study: PubMed 32101272Andrianello S, Marchegiani G, Malleo G, Masini G, Balduzzi A, Paiella S, Esposito A, Landoni L, Casetti L, Tuveri M, Salvia R, Bassi C. Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis: A Single-Center, Phase 3, Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):313-321. doi: 10.1001/jamasurg.2019.6035.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared with other researchers
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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. This study is not recruiting at the moment.
Claudio Bassi, MD principal investigator
Università degli studi di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreaticogastrostomy with external drain and Pancreaticojejunostomy with transanastomotic drain in people with Pancreatic Fistula, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 6 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: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pancreatic Fistula (POPF) (time frame: 30 days post-operative). 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 NCT03212196, which also lists 6 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 13 Sep 2019.