Clinical trial · Interventional
Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy
A Prospective Randomized Controlled Trial Comparing Isolated Roux-en-Y Reconstruction With Billroth-II-type Reconstruction After Pancreaticoduodenectomy
NCT00915863CI-TRIAL-00003061unknownN/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 purpose of this study is to evaluate the incidence of complications with the isolated Roux-en-Y reconstruction after pancreaticoduodenectomy in pancreatic tumor and periampullary tumor patients. A prospective randomized controlled trial was conducted to compare the incidence of complications with isolated Roux-en-Y reconstruction with those of Billroth-II-type reconstruction after pancreaticoduodenectomy.
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 |
|---|---|---|---|
| Ampullary Neoplasms | — | UNRESOLVED | — |
| Bile Duct Neoplasms | Bile Duct Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Duodenal Neoplasms | Duodenal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Billroth-II-type reconstruction | Procedure | — | UNRESOLVED |
| Isolated Roux-en-Y type reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Billroth-II-type
- description
- Billroth-II-type reconstruction after pancreaticoduodenectomy
- interventionNames
- Procedure: Billroth-II-type reconstruction
- type
- EXPERIMENTAL
- label
- Isolated Roux-en-Y
- description
- Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy
- interventionNames
- Procedure: Isolated Roux-en-Y type reconstruction
Primary outcomes (1)
- measure
- the incidence of pancreatic fistula
- timeFrame
- 3 months after operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * the patients had undergone pancreatic head resection at Wakayama Medical University the patients obtained appropriate informed consent Exclusion Criteria: * young patients (less than 20-years-old) * patients with severe complications which were possible to prolong hospital stay * patients undergone hemodialysis * patients combined resection of other organs * patients who were diagnosed inadequacy for this study by a physician * patients without an informed consent
References
Publications (7)
- BACKGROUNDKawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006 Jul;244(1):1-7. doi: 10.1097/01.sla.0000218077.14035.a6. PMID 16794381
- BACKGROUNDTani M, Kawai M, Terasawa H, Ina S, Hirono S, Uchiyama K, Yamaue H. Does postoperative chemotherapy have a survival benefit for patients with pancreatic cancer? J Surg Oncol. 2006 May 1;93(6):485-90. doi: 10.1002/jso.20440. PMID 16615151
- BACKGROUNDTani M, Terasawa H, Kawai M, Ina S, Hirono S, Uchiyama K, Yamaue H. Improvement of delayed gastric emptying in pylorus-preserving pancreaticoduodenectomy: results of a prospective, randomized, controlled trial. Ann Surg. 2006 Mar;243(3):316-20. doi: 10.1097/01.sla.0000201479.84934.ca. PMID 16495694
- BACKGROUNDTani M, Onishi H, Kinoshita H, Kawai M, Ueno M, Hama T, Uchiyama K, Yamaue H. The evaluation of duct-to-mucosal pancreaticojejunostomy in pancreaticoduodenectomy. World J Surg. 2005 Jan;29(1):76-9. doi: 10.1007/s00268-004-7507-0. PMID 15592915
- BACKGROUNDTani M, Kawai M, Terasawa H, Ueno M, Hama T, Hirono S, Ina S, Uchiyama K, Yamaue H. Complications with reconstruction procedures in pylorus-preserving pancreaticoduodenectomy. World J Surg. 2005 Jul;29(7):881-4. doi: 10.1007/s00268-005-7697-0. PMID 15951940
- DERIVEDBusquets J, Martin S, Fabregat J, Secanella L, Pelaez N, Ramos E. Randomized trial of two types of gastrojejunostomy after pancreatoduodenectomy and risk of delayed gastric emptying (PAUDA trial). Br J Surg. 2019 Jan;106(1):46-54. doi: 10.1002/bjs.11023. Epub 2018 Dec 3. PMID 30507039
- DERIVEDTani M, Kawai M, Hirono S, Okada KI, Miyazawa M, Shimizu A, Kitahata Y, Yamaue H. Randomized clinical trial of isolated Roux-en-Y versus conventional reconstruction after pancreaticoduodenectomy. Br J Surg. 2014 Aug;101(9):1084-91. doi: 10.1002/bjs.9544. Epub 2014 Jun 26.