Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Neoplasms; Pancreatic Fistula
• Intervention / Treatment: Procedure: Tri-Staple reloads; Procedure: traditional reloads

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 Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • HangZhou, Zhejiang, China, 310014
      • Zhejiang Provincial Peoples' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Thirty days after operation
Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell		intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Yi-Ping Mou
• Investigators: Study Director: YiPing Mou, MD, Department of Gastrointestinal-Pancreatic Surgery, Zhejiang Provincial Peoples' Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (ESTIMATE): June 3, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Neoplasms; Pancreatic Fistula
• Other Study ID Numbers: ZJPPH-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED