Pancreatic Stent for Distal Pancreatectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03314337

Enrollment

120

Registered

2017-10-19

Start date

2017-11-01

Completion date

2022-12-31

Last updated

2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Pancreatectomy

Keywords

Distal Pancreatectomy, Pancreatic stent, Post-operative pancreatic fistula

Brief summary

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

Interventions

DEVICEPancreatic stent: PSOF COOK®

After removing the distal pancreas, PSOF COOK will be place in the main pancreatic duct

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
all-cause mortality / complications	Hospitalization 30days（duration of hospital stay)	mortality, pancreatic fistula, Biliary fistula，bleeding， etc

Secondary

Measure	Time frame	Description
all-cause mortality / complications	30 days after operation	mortality, pancreatic fistula, Biliary fistula，bleeding， etc

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026