Pancreatic FistulaNCT03800940
Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial
A study testing Fistulography and trans-drain occlusion and Fistulography in people with Pancreatic Fistula, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a multicenter, investigator initiated, prospective, superiority, parallel-group, randomized, double-blinded trial that aims to compare the efficacy and safety of trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone for postoperative pancreatic fistula (POPF)… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Fistulography and trans-drain occlusion and Fistulography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jan 2019to 27 Mar 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo pancreatectomy (including pancreatoduodenectomy with or without pylorus preservation, distal pancreatectomy, and central pancreatectomy) and develop POPF that persists for 3 weeks after its occurrence.
- With POPF that persists for 3 weeks after occurrence
Who cannot join
- Younger than 20 years of age
- Active infection not adequately controlled [body temperature ≧38.5℃ and/or eukocytosis (WBC count >15,000 /uL)/leukopenia (WBC count <4,000 /uL)], have residual intra-abdominal fluid collection (largest diameter > 4cm) despite tube drainage on CT scan (with or without contrast, performed when the patient meet inclusion criteria).
- Current or history of severe heart, lung, kidney, or liver failure
- Karnofsky Performance Score <60
- Pregnant or lactating
- Have received somatostatin or its analogue in the index admission
- Decline to participate
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicenter, investigator initiated, prospective, superiority, parallel-group, randomized, double-blinded trial that aims to compare the efficacy and safety of trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone for postoperative pancreatic fistula (POPF) that persists for longer than 21 days.
Read the detailed description
The most common major complication after pancreatic resection is postoperative pancreatic fistula (POPF), which is defined as a drain output of any measurable volume of fluid on and after postoperative day 3 with an amylase content > 3 times the upper limit of normal serum level. Gradual withdrawal of surgically placed drains in patients who are clinically stable and tolerate a diet is generally adopted to hasten closure of POPF. For high-output fistulas (> 150-200 mL of amylase-rich fluid per day), patients are initially managed with fasting and enteral or parenteral nutrition. If fistula output decreases substantially with these measures and the patient remains clinically well, drain withdrawal is initiated and oral intake is slowly restarted. If the patient remains well despite high fistula output, drains are slowly withdrawn in an attempt to decrease the output and close the fistula. When the output decrease to less than 10 mL per day, the drains are removed.
However, the current standard practice of gradual drain withdrawal is time consuming. Although clinically stable can be discharged with the drain, the drainage tube often remains in place for a prolonged period, with patient discomfort and increased medical cost. In a pilot study by the investigators, 32.5% (37/114) of POPF patients required drainage for longer than 21 days. Besides, there is also considerable risk of recurrent fluid collection along the drain tube tract after drain removal.
The investigators' experience has shown that trans-drain occlusion of the drain tract achieves fistula closure, enabling immediate removal of the drain. In a pilot study, 20 patients underwent trans-catheter occlusion for POPFs that persisted for more than 3 weeks after placement of drainage tubes. No subjective symptoms or abnormalities in blood tests were noted in 17 patients after the procedure. Three patients had abdominal pain without signs of infection, and the pain spontaneously subsided after conservative treatment. POPF healed immediately after occlusion in all of the 20 patients without recurrence during follow-up. This multicenter, investigator initiated, prospective, superiority, parallel-group, randomized, double-blinded trial aims to compare the efficacy and safety of trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone for POPF that persists for longer than 21 days.
- Conditions
- Pancreatic Fistula
- Being tested
- Fistulography and trans-drain occlusion, Fistulography
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fistulography and trans-drain occlusionProcedure or surgery
- Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.
- Trans-drain occlusion: a 0.035-inch guidewire is inserted via the puncture needle. The drain tube is removed, cut at 4 cm proximal to the skin fixation site, and preserved for reinsertion. After inserting a 40cm 5Fr KMP catheter over the guidewire, the guidewire is removed. Afte rinsing the KMP catheter with 3ml 5% glucose water, withdraw the catheter and simultaneously inject glue (33%, 1:2, 0.5ml of NBCA + 1ml Lipiodol) into the catheter until the proximal 5cm of the catheter remains inside the tract. The guidewire is re-inserted through the catheter, and then the original drain tube is re-inserted over the guidewire. The guidewire is removed and the drain is fixed.
FistulographyProcedure or surgery
Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.
| Study group | Role | What they receive |
|---|---|---|
| Fistulography and trans-drain occlusion | Experimental | Fistulography is performed to assess the condition of the fistula, and trans-drain occlusion is performed by injecting glue (NBCA and Lipiodol) through the drain to occlude the tract. Receives: Procedure: Fistulography and trans-drain occlusion |
| Fistulography | Sham comparator | Fistulography is performed to assess the condition of the fistula, without trains-drain occlusion. Receives: Procedure: Fistulography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to fistula closure
Days from the randomly allocated treatment to fistula closure
Measured: The date of fistula closure is the date on which the drain is removed after an output of ≦ 10 mL during 48 hours, without recurrence of fistula within the next 3 months
Secondary outcomes (5)
30-day fistula closure rate
Proportion of patients in whom the drain can be removed by 30 days after occurrence of fistula, without recurrence within the next 3 months
Measured: From enrollment to 4 months after fistula occurrence
Rate of persistent or recurrent POPF after initial drain removal
Proportion of patients with fluid collection on follow-up CT, which is to be performed at 3 months after removal of drain or when recurrence of fistula is suspected clinically.
Measured: From drain removal to 3 months after drain removal or recurrence of fistula, whichever occurs first
Length of hospital stay after the assigned treatment
Days from the assigned treatment to discharge
Measured: From treatment to discharge from the index admission, an average of 2 weeks
Hospital costs after the assigned treatment
Costs from the assigned treatment to discharge
Measured: From treatment to discharge from the index admission, an average of 2 weeks
Rate of fistula-related complications
Proportion of patients who develop fever/infection, ileus, postpancreatectomy hemorrhage from the assigned treatment to end of follow-up.
Measured: From occurrence of fistula to 3 months after drain removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start11 Jan 2019
- Primary completion27 Nov 2022
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled patients will be randomly assigned in a 2:1 ratio to receive trans-drain occlusion followed by gradual drain withdrawal or gradual drain withdrawal.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Wen Tien, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800940
- Sponsor's protocol ID
- 201809040RIND
- Status last verified
- Mar 2023
- First submitted
- 2 Jan 2019
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schlitt HJ, Schmidt U, Simunec D, Jager M, Aselmann H, Neipp M, Piso P. Morbidity and mortality associated with pancreatogastrostomy and pancreatojejunostomy following partial pancreatoduodenectomy. Br J Surg. 2002 Oct;89(10):1245-51. doi: 10.1046/j.1365-2168.2002.02202.x.
PubMed 12296891Balcom 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 11296108Yeo CJ, Cameron JL, Sohn TA, Lillemoe KD, Pitt HA, Talamini MA, Hruban RH, Ord SE, Sauter PK, Coleman J, Zahurak ML, Grochow LB, Abrams RA. Six hundred fifty consecutive pancreaticoduodenectomies in the 1990s: pathology, complications, and outcomes. Ann Surg. 1997 Sep;226(3):248-57; discussion 257-60. doi: 10.1097/00000658-199709000-00004.
PubMed 9339931Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
PubMed 28040257Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
PubMed 16003309Roberts KJ, Sutcliffe RP, Marudanayagam R, Hodson J, Isaac J, Muiesan P, Navarro A, Patel K, Jah A, Napetti S, Adair A, Lazaridis S, Prachalias A, Shingler G, Al-Sarireh B, Storey R, Smith AM, Shah N, Fusai G, Ahmed J, Abu Hilal M, Mirza DF. Scoring System to Predict Pancreatic Fistula After Pancreaticoduodenectomy: A UK Multicenter Study. Ann Surg. 2015 Jun;261(6):1191-7. doi: 10.1097/SLA.0000000000000997.
PubMed 25371115El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5.
PubMed 23494109Veillette G, Dominguez I, Ferrone C, Thayer SP, McGrath D, Warshaw AL, Fernandez-del Castillo C. Implications and management of pancreatic fistulas following pancreaticoduodenectomy: the Massachusetts General Hospital experience. Arch Surg. 2008 May;143(5):476-81. doi: 10.1001/archsurg.143.5.476.
PubMed 18490557McMillan MT, Soi S, Asbun HJ, Ball CG, Bassi C, Beane JD, Behrman SW, Berger AC, Bloomston M, Callery MP, Christein JD, Dixon E, Drebin JA, Castillo CF, Fisher WE, Fong ZV, House MG, Hughes SJ, Kent TS, Kunstman JW, Malleo G, Miller BC, Salem RR, Soares K, Valero V, Wolfgang CL, Vollmer CM Jr. Risk-adjusted Outcomes of Clinically Relevant Pancreatic Fistula Following Pancreatoduodenectomy: A Model for Performance Evaluation. Ann Surg. 2016 Aug;264(2):344-52. doi: 10.1097/SLA.0000000000001537.
PubMed 26727086Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Buchler MW. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011 Apr 30;377(9776):1514-22. doi: 10.1016/S0140-6736(11)60237-7.
PubMed 21529927Tjaden C, Hinz U, Hassenpflug M, Fritz F, Fritz S, Grenacher L, Buchler MW, Hackert T. Fluid collection after distal pancreatectomy: a frequent finding. HPB (Oxford). 2016 Jan;18(1):35-40. doi: 10.1016/j.hpb.2015.10.006. Epub 2015 Nov 18.
PubMed 26776849
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03800940
- Acronym / sponsor ID
- 201809040RIND
- Conditions
- Pancreatic Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 11 Jan 2019 (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 is a multicenter, investigator initiated, prospective, superiority, parallel-group, randomized, double-blinded trial that aims to compare the efficacy and safety of trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone for postoperative pancreatic fistula (POPF) that persists for longer than 21 days.
Detailed description
The most common major complication after pancreatic resection is postoperative pancreatic fistula (POPF), which is defined as a drain output of any measurable volume of fluid on and after postoperative day 3 with an amylase content > 3 times the upper limit of normal serum level. Gradual withdrawal of surgically placed drains in patients who are clinically stable and tolerate a diet is generally adopted to hasten closure of POPF. For high-output fistulas (> 150-200 mL of amylase-rich fluid per day), patients are initially managed with fasting and enteral or parenteral nutrition. If fistula output decreases substantially with these measures and the patient remains clinically well, drain withdrawal is initiated and oral intake is slowly restarted. If the patient remains well despite high fistula output, drains are slowly withdrawn in an attempt to decrease the output and close the fistula. When the output decrease to less than 10 mL per day, the drains are removed.
However, the current standard practice of gradual drain withdrawal is time consuming. Although clinically stable can be discharged with the drain, the drainage tube often remains in place for a prolonged period, with patient discomfort and increased medical cost. In a pilot study by the investigators, 32.5% (37/114) of POPF patients required drainage for longer than 21 days. Besides, there is also considerable risk of recurrent fluid collection along the drain tube tract after drain removal.
The investigators' experience has shown that trans-drain occlusion of the drain tract achieves fistula closure, enabling immediate removal of the drain. In a pilot study, 20 patients underwent trans-catheter occlusion for POPFs that persisted for more than 3 weeks after placement of drainage tubes. No subjective symptoms or abnormalities in blood tests were noted in 17 patients after the procedure. Three patients had abdominal pain without signs of infection, and the pain spontaneously subsided after conservative treatment. POPF healed immediately after occlusion in all of the 20 patients without recurrence during follow-up. This multicenter, investigator initiated, prospective, superiority, parallel-group, randomized, double-blinded trial aims to compare the efficacy and safety of trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone for POPF that persists for longer than 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Enrolled patients will be randomly assigned in a 2:1 ratio to receive trans-drain occlusion followed by gradual drain withdrawal or gradual drain withdrawal.
| Arm | Type | Receives |
|---|---|---|
| Fistulography and trans-drain occlusion | Experimental | Procedure: Fistulography and trans-drain occlusionFistulography is performed to assess the condition of the fistula, and trans-drain occlusion is performed by injecting glue (NBCA and Lipiodol) through the drain to occlude the tract. |
| Fistulography | Sham comparator | Procedure: FistulographyFistulography is performed to assess the condition of the fistula, without trains-drain occlusion. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who undergo pancreatectomy (including pancreatoduodenectomy with or without pylorus preservation, distal pancreatectomy, and central pancreatectomy) and develop POPF that persists for 3 weeks after its occurrence.
- With POPF that persists for 3 weeks after occurrence
Key exclusion criteria (7 listed)
- Younger than 20 years of age
- Active infection not adequately controlled [body temperature ≧38.5℃ and/or eukocytosis (WBC count >15,000 /uL)/leukopenia (WBC count <4,000 /uL)], have residual intra-abdominal fluid collection (largest diameter > 4cm) despite tube drainage on CT scan (with or without contrast, performed when the patient meet inclusion criteria).
- Current or history of severe heart, lung, kidney, or liver failure
- Karnofsky Performance Score <60
- Pregnant or lactating
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 |
|---|---|---|
| Fistulography and trans-drain occlusion1. Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube. 2. Trans-drain occlusion: a 0.035-inch guidewire is inserted via the puncture needle. The drain tube is removed, cut at 4 cm proximal to the skin fixation site, and preserved for reinsertion. After inserting a 40cm 5Fr KMP catheter over the guidewire, the guidewire is removed. Afte rinsing the KMP catheter with 3ml 5% glucose water, withdraw the catheter and simultaneously inject glue (33%, 1:2, 0.5ml of NBCA + 1ml Lipiodol) into the catheter until the proximal 5cm of the catheter remains inside the tract. The guidewire is re-inserted through the catheter, and then the original drain tube is re-inserted over the guidewire. The guidewire is removed and the drain is fixed. | Procedure or surgery | Fistulography and trans-drain occlusion |
| FistulographyFistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube. | Procedure or surgery | Fistulography |
Primary outcome
Days to fistula closure
Time frame: The date of fistula closure is the date on which the drain is removed after an output of ≦ 10 mL during 48 hours, without recurrence of fistula within the next 3 months
Days from the randomly allocated treatment to fistula closure
5 secondary outcomes
30-day fistula closure rate
Time frame: From enrollment to 4 months after fistula occurrence
Rate of persistent or recurrent POPF after initial drain removal
Time frame: From drain removal to 3 months after drain removal or recurrence of fistula, whichever occurs first
Length of hospital stay after the assigned treatment
Time frame: From treatment to discharge from the index admission, an average of 2 weeks
Hospital costs after the assigned treatment
Time frame: From treatment to discharge from the index admission, an average of 2 weeks
Rate of fistula-related complications
Time frame: From occurrence of fistula to 3 months after drain removal
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 28 Mar 2023.
- Background: PubMed 12296891Schlitt HJ, Schmidt U, Simunec D, Jager M, Aselmann H, Neipp M, Piso P. Morbidity and mortality associated with pancreatogastrostomy and pancreatojejunostomy following partial pancreatoduodenectomy. Br J Surg. 2002 Oct;89(10):1245-51. doi: 10.1046/j.1365-2168.2002.02202.x.
- 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 9339931Yeo CJ, Cameron JL, Sohn TA, Lillemoe KD, Pitt HA, Talamini MA, Hruban RH, Ord SE, Sauter PK, Coleman J, Zahurak ML, Grochow LB, Abrams RA. Six hundred fifty consecutive pancreaticoduodenectomies in the 1990s: pathology, complications, and outcomes. Ann Surg. 1997 Sep;226(3):248-57; discussion 257-60. doi: 10.1097/00000658-199709000-00004.
- Background: PubMed 28040257Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
- Background: PubMed 16003309Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
- Background: PubMed 25371115Roberts KJ, Sutcliffe RP, Marudanayagam R, Hodson J, Isaac J, Muiesan P, Navarro A, Patel K, Jah A, Napetti S, Adair A, Lazaridis S, Prachalias A, Shingler G, Al-Sarireh B, Storey R, Smith AM, Shah N, Fusai G, Ahmed J, Abu Hilal M, Mirza DF. Scoring System to Predict Pancreatic Fistula After Pancreaticoduodenectomy: A UK Multicenter Study. Ann Surg. 2015 Jun;261(6):1191-7. doi: 10.1097/SLA.0000000000000997.
- Background: PubMed 23494109El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5.
- Background: PubMed 18490557Veillette G, Dominguez I, Ferrone C, Thayer SP, McGrath D, Warshaw AL, Fernandez-del Castillo C. Implications and management of pancreatic fistulas following pancreaticoduodenectomy: the Massachusetts General Hospital experience. Arch Surg. 2008 May;143(5):476-81. doi: 10.1001/archsurg.143.5.476.
- Background: PubMed 26727086McMillan MT, Soi S, Asbun HJ, Ball CG, Bassi C, Beane JD, Behrman SW, Berger AC, Bloomston M, Callery MP, Christein JD, Dixon E, Drebin JA, Castillo CF, Fisher WE, Fong ZV, House MG, Hughes SJ, Kent TS, Kunstman JW, Malleo G, Miller BC, Salem RR, Soares K, Valero V, Wolfgang CL, Vollmer CM Jr. Risk-adjusted Outcomes of Clinically Relevant Pancreatic Fistula Following Pancreatoduodenectomy: A Model for Performance Evaluation. Ann Surg. 2016 Aug;264(2):344-52. doi: 10.1097/SLA.0000000000001537.
- Background: PubMed 21529927Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Buchler MW. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011 Apr 30;377(9776):1514-22. doi: 10.1016/S0140-6736(11)60237-7.
- Background: PubMed 26776849Tjaden C, Hinz U, Hassenpflug M, Fritz F, Fritz S, Grenacher L, Buchler MW, Hackert T. Fluid collection after distal pancreatectomy: a frequent finding. HPB (Oxford). 2016 Jan;18(1):35-40. doi: 10.1016/j.hpb.2015.10.006. Epub 2015 Nov 18.
- Individual participant dataSharing planned: No
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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.
Yu-Wen Tien, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fistulography and trans-drain occlusion and Fistulography in people with Pancreatic Fistula, run by National Taiwan University Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 28 Mar 2023. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Days to fistula closure (time frame: The date of fistula closure is the date on which the drain is removed after an output of ≦ 10 mL during 48 hours, without recurrence of fistula within the next 3 months). 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 NCT03800940, which also lists 11 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 28 Mar 2023.