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

Tianjin Medical University

Status and phase: Unknown; Phase 2

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

Treatments: Procedure: Internal Drainage of Pancreatic Duct after pancreatomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01634971

CIH-WUQ-201205001

E2012010 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

External Drainage of pancreatic duct

No Intervention group

Description:

External Drainage of pancreatic duct was used in PD.

Internal Drainage of Pancreatic Duct

Experimental group

Description:

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.

Treatment:

Procedure: Internal Drainage of Pancreatic Duct after pancreatomy