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Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula

Primary Purpose

Pancreatic Neoplasms, Pancreatic Fistula

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
traditional reloads
Tri-Staple reloads
Sponsored by
Yi-Ping Mou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with severe organ disease such as cardiac disease,respiratory illness
  2. Patients with pancreaticojejunostomy,pancreatogastrostomy
  3. Patients with conversion to laparotomy
  4. Patients with pregnancy

Sites / Locations

  • Zhejiang Provincial Peoples' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tri-Staple reloads

traditional reloads

Arm Description

Tri-Staple reloads were used for pancreatic stump texture

the traditional reloads were used for pancreatic stump texture

Outcomes

Primary Outcome Measures

Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification
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
Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell

Secondary Outcome Measures

Morbidity
Mortality
Time to oral intake
Postoperative hospital stay
Readmission rate

Full Information

First Posted
May 31, 2016
Last Updated
January 6, 2021
Sponsor
Yi-Ping Mou
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1. Study Identification

Unique Protocol Identification Number
NCT02790333
Brief Title
Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula
Official Title
A Randomized Trail Of Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula After Laparoscopic Distal Pancreatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi-Ping Mou

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms, Pancreatic Fistula

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tri-Staple reloads
Arm Type
Experimental
Arm Description
Tri-Staple reloads were used for pancreatic stump texture
Arm Title
traditional reloads
Arm Type
Active Comparator
Arm Description
the traditional reloads were used for pancreatic stump texture
Intervention Type
Procedure
Intervention Name(s)
traditional reloads
Intervention Description
Blue cartridge with3.0mm height staple was used for pancreatic stump
Intervention Type
Procedure
Intervention Name(s)
Tri-Staple reloads
Intervention Description
Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump
Primary Outcome Measure Information:
Title
Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification
Description
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
Time Frame
Thirty days after operation
Title
Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
Thirty days after operation
Title
Mortality
Time Frame
Thirty days after operation
Title
Time to oral intake
Time Frame
Duration of hospital stay
Title
Postoperative hospital stay
Time Frame
Duration of hospital stay
Title
Readmission rate
Time Frame
Thirty days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YiPing Mou, MD
Organizational Affiliation
Department of Gastrointestinal-Pancreatic Surgery, Zhejiang Provincial Peoples' Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhejiang Provincial Peoples' Hospital
City
HangZhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula

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