Pancreatic Stent for Distal Pancreatectomy

Distal Pancreatectomy Clinical Trial

Official title:

A Prospective Randomized Controlled Study Comparing Outcomes of Distal Pancreatectomy With or Without Pancreatic Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314337
• Other study ID #: HBP-RCT-002
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare outcomes of patients undergoing distal pancreatectomy with or without pancreatic stent

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients undergoing distal pancreatectomy

2. Signed the informed consents

Exclusion Criteria:

1. Recurrence patients

2. pre-operative anti-cancer treatment

3. patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )

4. AJCC stage IV

5. pre operative oddi'ssphincter incision

6. operation non radical

7. pancreatic stent not at place

Related Conditions & MeSH terms

• Distal Pancreatectomy

Intervention

Device:
• Pancreatic stent: PSOF COOK®
After removing the distal pancreas, PSOF COOK will be place in the main pancreatic duct

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality / complications	mortality, pancreatic fistula, Biliary fistula,bleeding, etc	Hospitalization 30days(duration of hospital stay)
Secondary	all-cause mortality / complications	mortality, pancreatic fistula, Biliary fistula,bleeding, etc	30 days after operation