External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent After Pancreaticoduodenectomy (EDIDPD)
EDIDPD
Phase II Study of External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 3, 2012
CompletedFirst Posted
Study publicly available on registry
July 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 17, 2016
January 1, 2013
4.6 years
July 3, 2012
February 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
the rate of postoperative Surgical Complications
2 weeks after operation
Study Arms (2)
External Drainage of pancreatic duct
NO INTERVENTIONExternal Drainage of pancreatic duct was used in PD.
Internal Drainage of Pancreatic Duct
EXPERIMENTALthe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age more than 18 years.
- Received pancreatoduodenectomy.
- Informed consent has been signed.
You may not qualify if:
- Age less than 18 years
- Emergency surgery
- Past history of pancreatic surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Qiang WU, MD. Ph.D.
Tianjin Medical University Cancer Institute and Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2012
First Posted
July 6, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 17, 2016
Record last verified: 2013-01