Clinical trial · Observational
Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy
Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Periampullary Cancer and Risk Factors: A Prospective Multicenter Study
NCT05017207CI-TRIAL-00077244completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients who are diagnosed with periampullary cancer will be performed pancreaticoduodenectomy with 3 types of pancreatic-jejunal anastomosis reconstructions. The investigator will analysis the complication of pancreatic fistula about: the clinical symptoms, laboratory test changing, intra-operative morphology, the risk factors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Fistula | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient with periampullary cancer and pancreaticoduodenectomy
- description
- Only one group of patient with periampullary cancer
- interventionNames
- Procedure: Pancreaticoduodenectomy
Primary outcomes (2)
- measure
- Pancreatic fistula
- timeFrame
- 30 days of post-operative period
- description
- The investigator will describe the day that appears pancreatic fistula, the clinical symptoms, intra-operative morphology if being indicated to re-operate. The measurement tool to diagnose pancreatic fistula is fluid amylase on the POD3 (fluid amylse is 3 times compared to serum's amylase)
- measure
- Risk factors relate to pancreatic fistula
- timeFrame
- 30 days of post-operative period
- description
- The investigator will analyse some of the risk factors that relate to pancreatic fistula, including pre-operative factors (BMI, albumin, bilirubin, biliary drainage), intra-operative elements (pancreatic duct 's diameter, pancreatic textile, blood transfusion, portal vein reconstruction), and post-operative factors (abdominal drainage's volume, fluid amylase, abdominal abscess..). The investigator will use the multivariable regression model to determine the risk factors (p-value\<0.05)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with periampullary cancer and can be performed pancreaticoduodenectomy. * Pancreaticoduodenectomy with one of three types of pancreatic - duodenal anastomosis reconstructions. Exclusion Criteria: * The patient does not consent to participate in the study
References
Publications (1)
- BACKGROUNDKawaida H, Kono H, Hosomura N, Amemiya H, Itakura J, Fujii H, Ichikawa D. Surgical techniques and postoperative management to prevent postoperative pancreatic fistula after pancreatic surgery. World J Gastroenterol. 2019 Jul 28;25(28):3722-3737. doi: 10.3748/wjg.v25.i28.3722. PMID 31391768