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

Johns Hopkins University

Status: Terminated

Conditions: Delayed Gastric Emptying; Postoperative Pancreatic Fistula

Treatments: Procedure: Braun enteroenterostomy; Procedure: pancreaticoduodenectomy without Braun enteroenterostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01481753

NA_00021168

Details and patient eligibility

About

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).

Enrollment: 341 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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341 participants in 2 patient groups

Braun arm

Active Comparator group

Description:

patients received Braun enteroenterostomy

Treatment:

Procedure: Braun enteroenterostomy

Non Braun Arm

Active Comparator group

Description:

Patients do not receive a Braun enteroenterostomy

Treatment:

Procedure: pancreaticoduodenectomy without Braun enteroenterostomy