Pancreatic Fistula, Pancreatic Neoplasms
Conditions
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.
Interventions
PROCEDUREtraditional reloads
Blue cartridge with3.0mm height staple was used for pancreatic stump
PROCEDURETri-Staple reloads
Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump
Sponsors
Yi-Ping Mou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time to oral intake | Duration of hospital stay |
| Morbidity | Thirty days after operation |
| Readmission rate | Thirty days after operation |
| Postoperative hospital stay | Duration of hospital stay |
| Mortality | Thirty days after operation |
Countries
China
Outcome results
None listed