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

NCT01481753 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2017-03-06

No results posted yet for this study

Summary

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).

Conditions

  • Postoperative Pancreatic Fistula
  • Delayed Gastric Emptying

Interventions

PROCEDURE

pancreaticoduodenectomy without Braun enteroenterostomy

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

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.

Sponsors & Collaborators

Principal Investigators

  • Christopher L Wolfgang, MD, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481753 on ClinicalTrials.gov