Pancreatic Stent for Distal Pancreatectomy

NCT ID: NCT03314337

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Distal Pancreatectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Distal Pancreatectomy without pancreatic stent

Group Type NO_INTERVENTION

No interventions assigned to this group

Distal Pancreatectomy with pancreatic stent

pancreatic stent will be placed in the main pancreatic duct during the operation

Group Type EXPERIMENTAL

Pancreatic stent: PSOF COOK®

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pancreatic stent: PSOF COOK®

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Weishen WANG

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HBP-RCT-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preoperative Stent Study
NCT00501176 COMPLETED NA