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

NCT01481753 | Terminated DMC

• 1 other identifier: NA_00021168
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Pancreatic Fistula; Delayed Gastric Emptying

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• 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

Study Arms (2)

Braun arm

ACTIVE COMPARATOR

patients received Braun enteroenterostomy

Procedure: Braun enteroenterostomy

Non Braun Arm

ACTIVE COMPARATOR

Patients do not receive a Braun enteroenterostomy

Procedure: pancreaticoduodenectomy without Braun enteroenterostomy

Interventions

pancreaticoduodenectomy without Braun enteroenterostomy PROCEDURE

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

Also known as: No Braun

Non Braun Arm

Braun enteroenterostomy 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.

Braun arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing pancreaticoduodenectomy surgery at Johns Hopkins Hospital

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Christopher L Wolfgang, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 30, 2011
• Study Start: December 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

US (1)