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

Phase 2

• Conditions: Postoperative Fistula; Complications of Surgical and Medical Care: General Terms
• Interventions: Procedure: Internal Drainage of Pancreatic Duct after pancreatomy

• Registration Number: NCT01634971
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Status Verified: 2013-01
• Last Update Submitted: 2016-02-14
• Last Update Posted: 2016-02-17
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internal Drainage of Pancreatic Duct	Internal Drainage of Pancreatic Duct after pancreatomy	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.

Primary Outcome Measures

Name	Time	Method
the rate of Postoperative pancreatic fistula within 2 weeks after operation	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.

Secondary Outcome Measures

Name	Time	Method
the rate of postoperative Surgical Complications	2 weeks after operation	the rate of Postpancreatectomy hemorrhage(PPH);Delayed gastric emptying (DGE); Bile leakage after pancreatic surgery;Anastomotic leakage

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China