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NCT03822676 Clinical Trial

Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula

Pancreatic Fistula Clinical Trial

Official title:
Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula Before Segmental Pancreatectomy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03822676
Other study ID # ZS-1833
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 22, 2019
Est. completion date May 2022

Study information
Verified date January 2019
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 38
Est. completion date May 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Prophylactic pancreatic stent
Prophylactic pancreatic stent before segmental pancreatic surgery

Locations
Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative pancreatic fistula Grade B and C from postoperative day 3 to 30
Secondary Severity of pancreatic fistula 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. from postoperative day 3 to 30
Secondary Length of stay Length of hospital stay from postoperative day 1 to discharge
See also
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Not yet recruiting NCT05657366 - Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy N/A
Completed NCT03419676 - Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy Phase 3
Recruiting NCT05297136 - Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy N/A
Completed NCT00679952 - Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy Phase 3
Completed NCT00931554 - Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections N/A
Recruiting NCT04380506 - Validations of New cut-of for the Stratification of Postoperative Complications,Drains Management N/A
Recruiting NCT06283160 - Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy