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

Primary Purpose

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

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Internal Drainage of Pancreatic Duct after pancreatomy
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Fistula focused on measuring Postoperative pancreatic fistula(POPF);, Postpancreatectomy hemorrhage(PPH);, Delayed gastric emptying (DGE);, Bile leakage after pancreatic surgery;, Anastomotic leakage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

External Drainage of pancreatic duct

Internal Drainage of Pancreatic Duct

Arm Description

External Drainage of pancreatic duct was used in PD.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

the rate of postoperative Surgical Complications
the rate of Postpancreatectomy hemorrhage(PPH);Delayed gastric emptying (DGE); Bile leakage after pancreatic surgery;Anastomotic leakage

Full Information

First Posted
July 3, 2012
Last Updated
February 14, 2016
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01634971
Brief Title
External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent After Pancreaticoduodenectomy (EDIDPD)
Acronym
EDIDPD
Official Title
Phase II Study of External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Fistula, Complications of Surgical and Medical Care: General Terms
Keywords
Postoperative pancreatic fistula(POPF);, Postpancreatectomy hemorrhage(PPH);, Delayed gastric emptying (DGE);, Bile leakage after pancreatic surgery;, Anastomotic leakage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
External Drainage of pancreatic duct
Arm Type
No Intervention
Arm Description
External Drainage of pancreatic duct was used in PD.
Arm Title
Internal Drainage of Pancreatic Duct
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Internal Drainage of Pancreatic Duct after pancreatomy
Intervention 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.
Primary Outcome Measure Information:
Title
the rate of Postoperative pancreatic fistula within 2 weeks after operation
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.
Time Frame
within 2 weeks after operation
Secondary Outcome Measure Information:
Title
the rate of postoperative Surgical Complications
Description
the rate of Postpancreatectomy hemorrhage(PPH);Delayed gastric emptying (DGE); Bile leakage after pancreatic surgery;Anastomotic leakage
Time Frame
2 weeks after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang WU, MD. Ph.D.
Phone
18622221080
Email
wuqiangtianjin@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang WU, MD. Ph.D.
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang WU, MD. Ph.D.
Phone
18622221080
Email
wuqiangtianjin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Qiang WU, MD. Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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