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

This study has been terminated.
(last patient recruited Feb 2015,completion of data review; study data do not meet statistical significance to answer proposed study question)
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01481753
First received: November 10, 2011
Last updated: March 2, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    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 [ 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


Enrollment: 341
Study Start Date: December 2009
Study Completion Date: September 2016
Primary Completion Date: September 2016 (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   (Adult, Senior)
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
  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
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Christopher L Wolfgang, MD, PhD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01481753     History of Changes
Other Study ID Numbers: NA_00021168
Study First Received: November 10, 2011
Last Updated: March 2, 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

ClinicalTrials.gov processed this record on July 21, 2017