External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent After Pancreaticoduodenectomy (EDIDPD)

Study Overview
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Brief Summary
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Postoperative pancreatic fistula (POPF) and other surgical complications are common after pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct is important and a stent is usually placed in the operation, but it is still controversial whether the stent drainage is internal or external.

Detailed Description
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The current study is to compare the rate of Postoperative pancreatic fistula(POPF) and other surgical complications after pancreatoduodenectomy (PD).

Official Title
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Phase II Study of External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent

Conditions
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Postoperative Fistula, Complications of Surgical and Medical Care: General Terms

Intervention / Treatment
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* Procedure: Internal Drainage of Pancreatic Duct after pancreatomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 18 years. Received pancreatoduodenectomy. Informed consent has been signed. Exclusion Criteria: Age less than 18 years Emergency surgery Past history of pancreatic surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: External Drainage of pancreatic duct<br>External Drainage of pancreatic duct was used in PD. | |
| Experimental: Internal Drainage of Pancreatic Duct<br>the Intervention name is: Internal Drainage of Pancreatic Duct after pancreatomy, a stent was placed in the pancreatic duct, external drainage of the stent is defined as control group(the stent will be tans-abdomen and as a drainage of pancreatic fluid), and internal drainage of the stent is defined as interventional(or experimental) group, with the stent very short(2cm) and placed in jejunum. | Procedure: Internal Drainage of Pancreatic Duct after pancreatomy<br>* the Intervention name is: Internal Drainage of Pancreatic Duct after pancreatomy, a stent was placed in the pancreatic duct, external drainage of the stent is defined as control group(the stent will be tans-abdomen and as a drainage of pancreatic fluid), and internal drainage of the stent is defined as interventional(or experimental) group, with the stent very short(2cm) and placed in jejunum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of Postoperative pancreatic fistula within 2 weeks after operation | Postoperative pancreatic fistula (POPF) is defined as a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. | within 2 weeks after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of postoperative Surgical Complications | the rate of Postpancreatectomy hemorrhage(PPH);Delayed gastric emptying (DGE); Bile leakage after pancreatic surgery;Anastomotic leakage | 2 weeks after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pancreatic fistula(POPF);, Postpancreatectomy hemorrhage(PPH);, Delayed gastric emptying (DGE);, Bile leakage after pancreatic surgery;, Anastomotic leakage