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
NCT number | NCT02790333 |
Other study ID # | ZJPPH-04 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | December 1, 2018 |
Verified date | January 2021 |
Source | Zhejiang Provincial People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang Provincial Peoples' Hospital | HangZhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Yi-Ping Mou |
China,
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 |
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