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

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ClinicalTrials.gov Identifier: NCT01481753
Recruitment Status : Terminated (last patient recruited Feb 2015,completion of data review; study data do not meet statistical significance to answer proposed study question)
First Posted : November 30, 2011
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Postoperative Pancreatic Fistula Delayed Gastric Emptying Procedure: pancreaticoduodenectomy without Braun enteroenterostomy Procedure: Braun enteroenterostomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2009
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481753


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Christopher L Wolfgang, MD, PhD Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01481753     History of Changes
Other Study ID Numbers: NA_00021168
First Posted: November 30, 2011    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

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