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

NCT ID: NCT01634971

Last Updated: 2016-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-12-31

Brief Summary

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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

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

Conditions

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Postoperative Fistula Complications of Surgical and Medical Care: General Terms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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External Drainage of pancreatic duct

External Drainage of pancreatic duct was used in PD.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Internal Drainage of Pancreatic Duct after pancreatomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qiang WU, MD. Ph.D.

Role: STUDY_CHAIR

Tianjin Medical University Cancer Institute and Hospital

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiang WU, MD. Ph.D.

Role: CONTACT

18622221080

Facility Contacts

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Qiang WU, MD. Ph.D.

Role: primary

18622221080

Other Identifiers

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E2012010

Identifier Type: OTHER

Identifier Source: secondary_id

CIH-WUQ-201205001

Identifier Type: -

Identifier Source: org_study_id

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