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

Complications of Surgical and Medical Care: General Terms Clinical Trial

— EDIDPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01634971
• Other study ID #: CIH-WUQ-201205001
• Secondary ID: E2012010
• Status: Recruiting
• Phase: Phase 2
• First received: July 3, 2012
• Last updated: February 14, 2016
• Start date: May 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2013
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Qiang WU, MD. Ph.D.
• Phone: 18622221080
• Email: wuqiangtianjin[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications of Surgical and Medical Care: General Terms
• Postoperative Fistula

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No