Clinical trial · Interventional
Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy
Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy
NCT01384617CI-TRIAL-00023182completedN/AClinicalTrials.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)
The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pancreatitis | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cystic Lesions | — | UNRESOLVED | — |
| Pancreatic Neuroendocrine Tumors | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Pseudocysts | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Roux-en-Y anastomosis of the pancreatic stump | Procedure | — | UNRESOLVED |
| Stapling closure of the pancreatic stump | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Roux-en-Y anastomosis of the pancreatic stump
- description
- end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.
- interventionNames
- Procedure: Roux-en-Y anastomosis of the pancreatic stump
- type
- ACTIVE_COMPARATOR
- label
- Stapling closure of the pancreatic stump
- description
- Echelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples.
- interventionNames
- Procedure: Stapling closure of the pancreatic stump
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. disease of pancreatic body and tail 2. PS (ECOG Performance Status Scale):0-1 3. Age: 20 years or older 4. distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis. 5. Adequate organ functions filled the following criteria within two weeks from enrollment: 1.White blood cell： \>3,500/mm3 or \<12,000/mm3 2.Neutrophilic leukocyte \>2,000/mm3 3.Platelet\>100,000/mm3 4.Hemoglobin \> 9.0g/dL 5.Total bilirubin \<2.0mg/dL 6.AST and ALT\<150IU/L 7.Creatinine \<1.5mg/dL 6)Patients who can provide written informed consent Exclusion Criteria: 1. Patients with severe liver cirrhosis or active hepatitis 2. Patients with respiratory illness that requires oxygen administration 3. .Patients with chronic renal failure requiring dialysis 4. Patients with active duplicative malignant disease affecting adverse event 5. Others, patients who are unfit for the study as determined by the attending physician
References
Publications (9)
- BACKGROUNDOlah A, Issekutz A, Belagyi T, Hajdu N, Romics L Jr. Randomized clinical trial of techniques for closure of the pancreatic remnant following distal pancreatectomy. Br J Surg. 2009 Jun;96(6):602-7. doi: 10.1002/bjs.6620. PMID 19434697
- BACKGROUNDKleeff 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. PMID 17414606
- BACKGROUNDWagner M, Gloor B, Ambuhl M, Worni M, Lutz JA, Angst E, Candinas D. Roux-en-Y drainage of the pancreatic stump decreases pancreatic fistula after distal pancreatic resection. J Gastrointest Surg. 2007 Mar;11(3):303-8. doi: 10.1007/s11605-007-0094-2. PMID 17458602
- BACKGROUNDKnaebel 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. PMID 15852419
- RESULTDiener 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. PMID 21529927
- RESULTZhou W, Lv R, Wang X, Mou Y, Cai X, Herr I. Stapler vs suture closure of pancreatic remnant after distal pancreatectomy: a meta-analysis. Am J Surg. 2010 Oct;200(4):529-36. doi: 10.1016/j.amjsurg.2009.12.022. Epub 2010 Jun 9. PMID 20538249