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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Pancreatic Cancer Pancreatic Cystic Lesions Chronic Pancreatitis Pancreatic Neuroendocrine Tumors Pancreatic Pseudocysts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Roux-en-Y anastomosis of the pancreatic stump

Intervention Type PROCEDURE

end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.

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.

Group Type ACTIVE_COMPARATOR

Stapling closure of the pancreatic stump

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No