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OpenTrials
Completed

NCT Number: NCT03314337

Pancreatic Stent for Distal Pancreatectomy

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

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Key information

Conditions

Distal Pancreatectomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing distal pancreatectomy
  • Signed the informed consents

Exclusion criteria

  • 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

Treatment and study plan

Pancreatic stent: PSOF COOK®

Device

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

Primary outcomes

  1. all-cause mortality / complications

    Time frame: Hospitalization 30days（duration of hospital stay)

    mortality, pancreatic fistula, Biliary fistula，bleeding， etc

Secondary outcomes

  1. all-cause mortality / complications

    Time frame: 30 days after operation

    mortality, pancreatic fistula, Biliary fistula，bleeding， etc

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2017
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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