Phase II Study of External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent
18 Years
80 Years
Both
Postoperative Fistula, Complications of Surgical and Medical Care: General Terms
Trial Information
Phase II Study of External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent
The current study is to compare the rate of Postoperative pancreatic fistula(POPF) and other
surgical complications after pancreatoduodenectomy (PD).
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
the rate of Postoperative pancreatic fistula within 2 weeks after operation
Outcome Description:
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.
Outcome Time Frame:
within 2 weeks after operation
Safety Issue:
No
Principal Investigator
Qiang WU, MD. Ph.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Tianjin Medical University Cancer Institute and Hospital
Authority:
China: Ministry of Health
Study ID:
CIH-WUQ-201205001
NCT ID:
NCT01634971
Start Date:
May 2012
Completion Date:
December 2015
Related Keywords:
- Postoperative Fistula
- Complications of Surgical and Medical Care: General Terms
- Postoperative pancreatic fistula(POPF);
- Postpancreatectomy hemorrhage(PPH);
- Delayed gastric emptying (DGE);
- Bile leakage after pancreatic surgery;
- Anastomotic leakage
- Fistula
Name | Location |
|---|
