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

Not Applicable

Terminated

• Conditions: Postoperative Pancreatic Fistula; Delayed Gastric Emptying
• Interventions: Procedure: Braun enteroenterostomy; Procedure: pancreaticoduodenectomy without Braun enteroenterostomy

• Registration Number: NCT01481753
• Lead Sponsor: Johns Hopkins University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-11-30
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 341

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Braun arm	Braun enteroenterostomy	patients received Braun enteroenterostomy
Non Braun Arm	pancreaticoduodenectomy without Braun enteroenterostomy	Patients do not receive a Braun enteroenterostomy

Primary Outcome Measures

Name	Time	Method
Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy	patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery	patients will be assessed for post operative fistula and delayed gastric emptying during hospitalization and then interviewed at 90 days +/- 2 weeks from OR date to assess any unanticipated consequences after discharge. We are currently performing statistical analysis of outcome data on the first 100 consented whipple patients as outlined in Johns Hopkins Hospital (JHH)-approved Institutional Review Board (IRB) protocol.

Secondary Outcome Measures

Name	Time	Method
Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy	patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery	patients will be assessed for post operative fistula and delayed gastric emptying during hospitalization and then interviewed at 90 days +/- 2 weeks from OR date to assess any unanticipated consequences after discharge We are currently performing statistical analysis of outcome data on the first 100 consented whipple patients as outlined in JHH-approved IRB protocol

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States