Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Pancreatic Fistula and Delayed Gastric Emptying

NCT ID: NCT01481753

Last Updated: 2017-03-06

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

TERMINATED

Clinical Phase

NA

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2016-09-30

Brief Summary

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The investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or Delayed Gastric Emptying (DGE).

Detailed Description

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Conditions

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Postoperative Pancreatic Fistula Delayed Gastric Emptying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Braun arm

patients received Braun enteroenterostomy

Group Type ACTIVE_COMPARATOR

Braun enteroenterostomy

Intervention Type PROCEDURE

addition of Braun enteroenterostomy (side-to-side anastomosis between the afferent and efferent loops of the gastrojejunostomy) to standard PD reconstruction can decrease the rates of POPF and/or DGE, improving the perioperative outcome of patients undergoing PD.

Non Braun Arm

Patients do not receive a Braun enteroenterostomy

Group Type ACTIVE_COMPARATOR

pancreaticoduodenectomy without Braun enteroenterostomy

Intervention Type PROCEDURE

no Braun enteroenterostomy has been added to standard pancreaticoduodenectomy; pancreaticoduodenectomy without Braun enteroenterostomy

Interventions

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pancreaticoduodenectomy without Braun enteroenterostomy

no Braun enteroenterostomy has been added to standard pancreaticoduodenectomy; pancreaticoduodenectomy without Braun enteroenterostomy

Intervention Type PROCEDURE

Braun enteroenterostomy

addition of Braun enteroenterostomy (side-to-side anastomosis between the afferent and efferent loops of the gastrojejunostomy) to standard PD reconstruction can decrease the rates of POPF and/or DGE, improving the perioperative outcome of patients undergoing PD.

Intervention Type PROCEDURE

Other Intervention Names

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No Braun

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing pancreaticoduodenectomy surgery at Johns Hopkins Hospital

Exclusion Criteria

* Pregnant women
* Patients under the age of 18
* adults lacking ability to consent,
* patients scheduled for laparoscopic whipple surgery
* non-english-speakers, and
* prisoners
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher L Wolfgang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00021168

Identifier Type: -

Identifier Source: org_study_id

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