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

Study Overview
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Brief Summary
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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).

Conditions
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Postoperative Pancreatic Fistula, Delayed Gastric Emptying

Intervention / Treatment
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* Procedure: pancreaticoduodenectomy without Braun enteroenterostomy
* Procedure: Braun enteroenterostomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Braun arm<br>patients received Braun enteroenterostomy | Procedure: Braun enteroenterostomy<br>* 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.<br>|
| Active Comparator: Non Braun Arm<br>Patients do not receive a Braun enteroenterostomy | Procedure: pancreaticoduodenectomy without Braun enteroenterostomy<br>* no Braun enteroenterostomy has been added to standard pancreaticoduodenectomy; pancreaticoduodenectomy without Braun enteroenterostomy<br>* Other names: No Braun;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy | 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. | patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy | 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 | patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery |