Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790333
• Other study ID #: ZJPPH-04
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2021
• Source: Zhejiang Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula
• Pancreatic Neoplasms

Intervention

Procedure:
• traditional reloads
Blue cartridge with3.0mm height staple was used for pancreatic stump
• Tri-Staple reloads
Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump

Locations

Country	Name	City	State
China	Zhejiang Provincial Peoples' Hospital	HangZhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Yi-Ping Mou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell		intraoperative
Secondary	Morbidity		Thirty days after operation
Secondary	Mortality		Thirty days after operation
Secondary	Time to oral intake		Duration of hospital stay
Secondary	Postoperative hospital stay		Duration of hospital stay
Secondary	Readmission rate		Thirty days after operation