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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Christopher L. Wolfgang, MD, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01481753
First received: November 10, 2011
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Postoperative Pancreatic Fistula
Delayed Gastric Emptying
Procedure: pancreaticoduodenectomy without Braun enteroenterostomy
Procedure: Braun enteroenterostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy [ Time Frame: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy [ Time Frame: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 304
Study Start Date: December 2009
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Braun arm
patients received 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.
Active Comparator: Non Braun Arm
Patients do not receive a Braun enteroenterostomy
Procedure: pancreaticoduodenectomy without Braun enteroenterostomy
no Braun enteroenterostomy has been added to standard pancreaticoduodenectomy; pancreaticoduodenectomy without Braun enteroenterostomy
Other Name: No Braun

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481753

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Christopher L Wolfgang, MD, PhD    410-502-4194    cwolfga2@jhmi.edu   
Contact: Mary B Hodgin, MS, BSN    410-614-8817    mhodgin1@jhmi.edu   
Principal Investigator: Christopher L Wolfgang, MD, PhD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Christopher L Wolfgang, MD, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Christopher L. Wolfgang, MD, PhD, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01481753     History of Changes
Other Study ID Numbers: NA_00021168
Study First Received: November 10, 2011
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fistula
Gastroparesis
Pancreatic Fistula
Digestive System Diseases
Digestive System Fistula
Gastrointestinal Diseases
Neurologic Manifestations
Pancreatic Diseases
Paralysis
Pathological Conditions, Anatomical
Signs and Symptoms
Stomach Diseases

ClinicalTrials.gov processed this record on October 29, 2014