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

Primary Purpose

Postoperative Pancreatic Fistula, Delayed Gastric Emptying

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

pancreaticoduodenectomy without Braun enteroenterostomy

Braun enteroenterostomy

About this trial

This is an interventional treatment trial for Postoperative Pancreatic Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Braun arm

Non Braun Arm

Arm Description

patients received Braun enteroenterostomy

Patients do not receive a Braun enteroenterostomy

Outcomes

Primary Outcome Measures

Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy

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

Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy

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

Full Information

NCT ID

NCT01481753

First Posted

November 10, 2011

Last Updated

March 2, 2017

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT01481753

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Why Stopped

last patient recruited Feb 2015,completion of data review; study data do not meet statistical significance to answer proposed study question

Study Start Date

December 2009 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pancreatic Fistula, Delayed Gastric Emptying

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

341 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Braun arm

Arm Type

Active Comparator

Arm Description

patients received Braun enteroenterostomy

Arm Title

Non Braun Arm

Arm Type

Active Comparator

Arm Description

Patients do not receive a Braun enteroenterostomy

Intervention Type

Procedure

Intervention Name(s)

pancreaticoduodenectomy without Braun enteroenterostomy

Other Intervention Name(s)

No Braun

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Braun enteroenterostomy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy

Description

Time Frame

patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery

Secondary Outcome Measure Information:

Title

Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy

Description

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

Time Frame

patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher L Wolfgang, MD, PhD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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