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

Johns Hopkins University341 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

341

Conditions

Postoperative Pancreatic Fistula Delayed Gastric Emptying

Interventions

pancreaticoduodenectomy without Braun enteroenterostomyPROCEDURE

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

Braun enteroenterostomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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