Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03822676
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 39.3
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Fistula	Device: Prophylactic pancreatic stent	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula Before Segmental Pancreatectomy
• Actual Study Start Date: Jan 22, 2019
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stent Prophylactic pancreatic stent before segmental pancreatic surgery	Device: Prophylactic pancreatic stent; Prophylactic pancreatic stent before segmental pancreatic surgery
No Intervention: No stent No prophylactic stent before surgery

Outcome Measures

Primary Outcome Measures

1. Postoperative pancreatic fistula [from postoperative day 3 to 30]

   Grade B and C

Secondary Outcome Measures

1. 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.

2. Length of stay [from postoperative day 1 to discharge]

   Length of hospital stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT03822676
• Other Study ID Numbers: ZS-1833
• First Posted: Jan 30, 2019
• Last Update Posted: Jan 30, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Fistula; Fistula

Study Results

No Results Posted as of Jan 30, 2019