Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT02343302
Status:
TERMINATED
Last Update Posted:
2021-12-21
First Post:
2015-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor patient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A very common complication following distal pancreatectomy is leakage from the pancreas, or what is called a pancreatic fistula. We hypothesize that operative drains which create suction may contribute to the development of leakage from the pancreas. This study evaluates the effect of using non-suctioning drains to prevent the development of this complication.
Detailed Description:
The most common complication following distal pancreatectomy is the developement of leakage from the remaining pancreas gland, which results in significant morbidity. Most surgeons leave dains at the time of surgery to prevent complications from pancreatic leakage. However, we hypothesize that drains which create continous negative pressure may contribute to the development of a pancreatic fistula. This study randomizes patients to suctioning versus non-suctioning drains. The primary endpoint is the development of pancreatic fistuale, as defined by the International Study Group of Pancreatic Surgery.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IRB00197557 | OTHER | Johns Hopkins IRB | View |