Skip to main content
OpenTrials
Completed

NCT Number: NCT02790333

Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula

The purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Provincial Peoples' Hospital

Hangzhou, Zhejiang, 310014, China

About this study

Distal pancreatectomy (DP) is the standard treatment for symptomatic benign, premalignant, and malignant lesions in the pancreatic body and tail.Laparoscopic distal pancreatectomy (LDP) are reported to have lower blood loss, fewer postoperative complications and a shorter length of stay without a substantial increase in the operative time. Pancreatic fistula (PF) is the major source of postoperative morbidity and is associated with numerous further complications, suffering, longer hospital stay, higher costs and sometimes death. Frequencies range from 5% to 64%. Several procedures have been proposed to reduce the rate of PF. stapler closure is considered to be safe and approved particularly in LDP. Numerous predictive factors for PF have been reported in previous studies. Among these risk factors, the most important might be the texture and thickness of the remnant pancreas. However, the judgment of pancreatic texture has been based on the surgeon's observation and there still exists no objective method of assessing pancreatic texture. Furthermore there is no strict guideline on which type of cartridge to use according to pancreatic stump texture and thickness. Therefore, this single blind randomized controlled trial is designed to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness. Patients were stratified intraoperatively by gland texture-hard (fibrotic) or soft (normal) and subsequently randomized according to different stapler cartridge. Pancreatic fibrosis is accessed by histopathology and pancreatic stellate cell.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • disease of pancreatic body and tail
  • Age: 18 years or older
  • distant metastases are not diagnosed preoperatively.
  • Patients who can provide written informed consent

Exclusion criteria

  • Patients with severe organ disease such as cardiac disease,respiratory illness
  • Patients with pancreaticojejunostomy,pancreatogastrostomy
  • Patients with conversion to laparotomy
  • Patients with pregnancy

Treatment and study plan

traditional reloads

Procedure

Blue cartridge with3.0mm height staple was used for pancreatic stump

Tri-Staple reloads

Procedure

Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump

Primary outcomes

  1. Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification

    Time frame: Thirty days after operation

    Pancreatic amylase concentration in any post operative drains. Fistula is diagnosed if pancreatic amylase > 3 times the upper normal limit of pancreatic amylase in plasma on post operative day 3 or later

  2. Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell

    Time frame: intraoperative

Secondary outcomes

  1. Morbidity

    Time frame: Thirty days after operation

  2. Mortality

    Time frame: Thirty days after operation

  3. Time to oral intake

    Time frame: Duration of hospital stay

  4. Postoperative hospital stay

    Time frame: Duration of hospital stay

  5. Readmission rate

    Time frame: Thirty days after operation

Sponsors and collaborators

Lead sponsor

Yi-Ping Mou

Other

Registry information

Official study title

A Randomized Trail Of Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula After Laparoscopic Distal Pancreatectomy

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 3, 2016
Registry last updated
Jan 8, 2021

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.

Published trials that share one or more normalized conditions with this study.