TerminatedNot Applicable

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

Stopped: last patient recruited Feb 2015,completion of data review; study data do not meet statistical significance to answer proposed study question

United States341 participantsStarted 2009-12

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy

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

Trial details

NCT IDNCT01481753

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Postoperative Pancreatic Fistula trials