Pancreatic Fistula
Conditions
Brief summary
Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. However, the results of prospective RCTs for the prophylactic effect of pancreatic stent insertion against POPF were controversial. This single center prospective randomized trial was designed to compare the outcome after segmental pancreatectomy with prophylactic drainage stent versus no stent.
Interventions
Prophylactic pancreatic stent before segmental pancreatic surgery
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients scheduled for elective segmental pancreatectomy
Exclusion criteria
* Subjects for whom ERCP procedures are contraindicated * If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding * Age less than 18 year * Emergency surgery * Previous pancreatic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pancreatic fistula | from postoperative day 3 to 30 | Grade B and C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of pancreatic fistula | from postoperative day 3 to 30 | Grade B POPF requires changes in clinical management, such as persistent drainage, partial or total parenteral nutrition, antibiotics, enteral nutrition, somatostatin analogs, and/or minimal invasive drainage. Grade C POPF requires major changes in management, such as admission to an intensive care unit, reoperation, and/or an extended hospital stay. |
| Length of stay | from postoperative day 1 to discharge | Length of hospital stay |
Countries
China
Outcome results
None listed