Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
last patient recruited Feb 2015,completion of data review; study data do not meet statistical significance to answer proposed study question
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Braun arm | Active Comparator | patients received Braun enteroenterostomy |
|
| Non Braun Arm | Active Comparator | Patients do not receive a Braun enteroenterostomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pancreaticoduodenectomy without Braun enteroenterostomy | Procedure | no Braun enteroenterostomy has been added to standard pancreaticoduodenectomy; pancreaticoduodenectomy without Braun enteroenterostomy |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher L Wolfgang, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Braun enteroenterostomy | Procedure | 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. |
|
| patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery |
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided