NCT03314337

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

5.1 years

First QC Date

October 6, 2017

Last Update Submit

October 16, 2023

Conditions

Distal Pancreatectomy

Keywords

Distal PancreatectomyPancreatic stentPost-operative pancreatic fistula

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality / complications

    mortality, pancreatic fistula, Biliary fistula，bleeding， etc

    Hospitalization 30days（duration of hospital stay)

Secondary Outcomes (1)

  • all-cause mortality / complications

    30 days after operation

Study Arms (2)

Distal Pancreatectomy without pancreatic stent

NO INTERVENTION

Distal Pancreatectomy with pancreatic stent

EXPERIMENTAL

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

Device: Pancreatic stent: PSOF COOK®

Interventions

Pancreatic stent: PSOF COOK®DEVICE

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

Distal Pancreatectomy with pancreatic stent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing distal pancreatectomy
  • Signed the informed consents

You may not qualify if:

  • Recurrence patients
  • pre-operative anti-cancer treatment
  • patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
  • AJCC stage IV
  • pre operative oddi'ssphincter incision
  • operation non radical
  • pancreatic stent not at place

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 19, 2017

Study Start

November 1, 2017

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations

CN(1)