Clinical trial NCT02790333: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Pancreatic Fistula
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification
timeFrame: Thirty days after operation
measure: Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell
timeFrame: intraoperative
Secondary outcomes:
measure: Morbidity
timeFrame: Thirty days after operation
measure: Mortality
timeFrame: Thirty days after operation
measure: Time to oral intake
timeFrame: Duration of hospital stay
measure: Postoperative hospital stay
timeFrame: Duration of hospital stay
measure: Readmission rate
timeFrame: Thirty days after operation
Other outcomes:
Locations:
city: HangZhou
country: China
facility: Zhejiang Provincial Peoples' Hospital
state: Zhejiang
Study officials:
affiliation: Department of Gastrointestinal-Pancreatic Surgery, Zhejiang Provincial Peoples' Hospital
name: YiPing Mou, MD
role: STUDY_DIRECTOR
References: