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

Study Overview
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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.

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 .

Official Title
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Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy

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

Intervention / Treatment
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* Procedure: Stapling closure of the pancreatic stump
* Procedure: Roux-en-Y anastomosis of the pancreatic stump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: disease of pancreatic body and tail PS (ECOG Performance Status Scale):0-1 Age: 20 years or older 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. 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: Patients with severe liver cirrhosis or active hepatitis Patients with respiratory illness that requires oxygen administration .Patients with chronic renal failure requiring dialysis Patients with active duplicative malignant disease affecting adverse event Others, patients who are unfit for the study as determined by the attending physician

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Roux-en-Y anastomosis of the pancreatic stump<br>end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa. | Procedure: Roux-en-Y anastomosis of the pancreatic stump<br>* end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.<br>|
| Active Comparator: Stapling closure of the pancreatic stump<br>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. | Procedure: Stapling closure of the pancreatic stump<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pancreatic fistula defined by ISGPF classification |  | 3 month after operation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal pancreatectomy, pancreatic fistula, pancreaticojejunostomy, Roux-en-Y anastomosis, stapling closure