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

This study is currently recruiting participants.
Verified January 2013 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01634971
First received: July 3, 2012
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Postoperative Fistula
Complications of Surgical and Medical Care: General Terms
 Procedure: Internal Drainage of Pancreatic Duct after pancreatomy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent

Resource links provided by NLM:

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • the rate of Postoperative pancreatic fistula within 2 weeks after operation [ Time Frame: within 2 weeks after operation ] [ Designated as safety issue: No ]
    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:
  • the rate of postoperative Surgical Complications [ Time Frame: 2 weeks after operation ] [ Designated as safety issue: No ]
    the rate of Postpancreatectomy hemorrhage(PPH);Delayed gastric emptying (DGE); Bile leakage after pancreatic surgery;Anastomotic leakage


Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: External Drainage of pancreatic duct
External Drainage of pancreatic duct was used in PD.
Experimental: Internal Drainage of Pancreatic Duct
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
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634971

Contacts
Contact: Qiang WU, MD. Ph.D. 18622221080 wuqiangtianjin@hotmail.com

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Qiang WU, MD. Ph.D.     18622221080     wuqiangtianjin@hotmail.com    
Principal Investigator: Qiang WU, MD. Ph.D.            
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Study Chair: Qiang WU, MD. Ph.D. Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01634971     History of Changes
Other Study ID Numbers: CIH-WUQ-201205001, E2012010
Study First Received: July 3, 2012
Last Updated: January 22, 2013
Health Authority: China: Ministry of Health

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Postoperative pancreatic fistula(POPF);
Postpancreatectomy hemorrhage(PPH);
Delayed gastric emptying (DGE);
Bile leakage after pancreatic surgery;
Anastomotic leakage

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013