Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula

Sponsor

Yi-Ping Mou (Other)

Overall Status

Completed

CT.gov ID

NCT02790333

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms Pancreatic Fistula	Procedure: traditional reloads Procedure: Tri-Staple reloads	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tri-Staple reloads Tri-Staple reloads were used for pancreatic stump texture	Procedure: Tri-Staple reloads Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump
Active Comparator: traditional reloads the traditional reloads were used for pancreatic stump texture	Procedure: traditional reloads Blue cartridge with3.0mm height staple was used for pancreatic stump

Arm

Intervention/Treatment

Experimental: Tri-Staple reloads

Tri-Staple reloads were used for pancreatic stump texture

Procedure: Tri-Staple reloads

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

Active Comparator: traditional reloads

the traditional reloads were used for pancreatic stump texture

Procedure: traditional reloads

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Morbidity [Thirty days after operation]
Mortality [Thirty days after operation]
Time to oral intake [Duration of hospital stay]
Postoperative hospital stay [Duration of hospital stay]
Readmission rate [Thirty days after operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Provincial Peoples' Hospital	HangZhou	Zhejiang	China	310014

Sponsors and Collaborators

Yi-Ping Mou

Investigators

Study Director: YiPing Mou, MD, Department of Gastrointestinal-Pancreatic Surgery, Zhejiang Provincial Peoples' Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yi-Ping Mou, MD，Director, Zhejiang Provincial People's Hospital

ClinicalTrials.gov Identifier:

NCT02790333

Other Study ID Numbers:

ZJPPH-04

First Posted:

Jun 3, 2016

Last Update Posted:

Jan 8, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Pancreatic Neoplasms

Pancreatic Fistula

Fistula

Study Results

No Results Posted as of Jan 8, 2021