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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00915863
Enrollment
150
Registered
2009-06-08
Start date
2009-06-30
Completion date
2014-03-31
Last updated
2010-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ampullary Neoplasms, Bile Duct Neoplasms, Duodenal Neoplasms, Pancreatic Neoplasms, Pancreatitis

Keywords

pancreaticoduodenectomy, pancreatic fistula, reconstruction, isolated Roux-en-Y

Brief summary

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.

Detailed description

The purpose of this study is to clarify whether isolated Roux-en-Y reconstruction declines the incidence of postoperative complications after pancreaticoduodenectomy compared with Billroth-II-type reconstruction. Especially, it is important to decline the incidence of pancreatic fistula, because pancreatic fistula affects a postoperative course. However, there is no report that demonstrated postoperative complications of isolated Roux-en-Y compared with those of Billroth-II-type reconstruction. We conducted a prospective randomized trial on patients who underwent pancreaticoduodenectomy. Patients with pancreatico-biliary disease who were performed pancreaticoduodenectomy at Wakayama Medical University Hospital. The primary endpoint was defined as the incidence of pancreatic fistula. The secondary endpoints were the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at Wakayama Medical University Hospital (WMUH) for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) young patients (less than 20-year-old), 2) patients with severe complications which were possible to prolong hospital stay, 3) patients undergone hemodialysis, 4) patients combined resection of other organs, 5) patients who were diagnosed inadequacy for this study by a physician, and 6) patients without an informed consent.

Interventions

PROCEDUREBillroth-II-type reconstruction

surgical procedure

PROCEDUREIsolated Roux-en-Y type reconstruction

surgical procedure

Sponsors

Wakayama Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
the incidence of pancreatic fistula3 months after operation

Secondary

MeasureTime frame
the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess3 months after operation

Countries

Japan

Contacts

Primary ContactHiroki Yamaue, MD
yamaue-h@wakayama-med.ac.jp81-73-441-0612

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026