Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

Not Applicable

Completed

• Conditions: Pancreatic Cystic Lesions; Pancreatic Cancer; Chronic Pancreatitis; Pancreatic Neuroendocrine Tumors; Pancreatic Pseudocysts
• Interventions: Procedure: Stapling closure of the pancreatic stump; Procedure: Roux-en-Y anastomosis of the pancreatic stump

• Registration Number: NCT01384617
• Lead Sponsor: Wakayama Medical University

Brief Summary

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.

Detailed Description

The objective of this study was to clarify Roux-en-Y anastomosis of the pancreatic stump prevents pancreatic fistula after distal pancreatectomy (DP) compared to stapling closure of the pancreatic stump in a prospective randomized controlled trail.

Various methods and technique for treating surgical stump of the remnant pancreas have been reported to reduce pancreatic fistula after DP. However, appropriate surgical stump closure after DP is still controversial.

The primary endpoint in this trial was defined as the incidence of pancreatic fistula .

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-29
• Primary Completion: 2014-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapling closure of the pancreatic stump	Stapling closure of the pancreatic stump	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.
Roux-en-Y anastomosis of the pancreatic stump	Roux-en-Y anastomosis of the pancreatic stump	end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.

Primary Outcome Measures

Name	Time	Method
Incidence of pancreatic fistula defined by ISGPF classification	3 month after operation

Secondary Outcome Measures

Name	Time	Method
postoperative hospital stay	3 month after operation
Incidence of pancreatic fistula grade B/C stratified based on thickness of pancreas parenchyma	3 months after oepration
morbidity	3 months after opeartion
nutritional status	2 years after opeartion
Incidence of pancreatic fistula gradeB/C defined by ISGPF classification	3 months after oepration
quality of life	2 years after operation
new onset or worsening diabetes	2 years after opeartion
mortality	3 months after operation
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma	3 months after operation

Trial Locations

Locations (1)

Second Department of Surgery, Wakayama Medical University, School of Medicine; 🇯🇵 Wakayama, Japan