Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula

NCT ID: NCT03822676

Last Updated: 2019-01-30

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

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-22

Study Completion Date

2022-05-31

Brief Summary

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Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. However, the results of prospective RCTs for the prophylactic effect of pancreatic stent insertion against POPF were controversial. This single center prospective randomized trial was designed to compare the outcome after segmental pancreatectomy with prophylactic drainage stent versus no stent.

Detailed Description

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Conditions

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Pancreatic Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Stent

Prophylactic pancreatic stent before segmental pancreatic surgery

Group Type EXPERIMENTAL

Prophylactic pancreatic stent

Intervention Type DEVICE

Prophylactic pancreatic stent before segmental pancreatic surgery

No stent

No prophylactic stent before surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prophylactic pancreatic stent

Prophylactic pancreatic stent before segmental pancreatic surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients scheduled for elective segmental pancreatectomy

Exclusion Criteria

* Subjects for whom ERCP procedures are contraindicated
* If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
* Age less than 18 year
* Emergency surgery
* Previous pancreatic surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Aiming Yang, M.D.

Role: primary

+86-10-69151593

Other Identifiers

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ZS-1833

Identifier Type: -

Identifier Source: org_study_id

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