Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula

Yi-Ping Mou

Status: Completed

Conditions: Pancreatic Fistula; Pancreatic Neoplasms

Treatments: Procedure: traditional reloads; Procedure: Tri-Staple reloads

Study type: Interventional

Funder types: Other

Identifiers

NCT02790333

ZJPPH-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

Tri-Staple reloads

Experimental group

Description:

Tri-Staple reloads were used for pancreatic stump texture

Treatment:

Procedure: Tri-Staple reloads

traditional reloads

Active Comparator group

Description:

the traditional reloads were used for pancreatic stump texture

Treatment:

Procedure: traditional reloads