A Modified Omental Patch Work Decreases Pancreatic Fistula After Laparoscopic Pancreaticoduodenectomy
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- pancreatic fistula
Study Overview
Brief Summary
Pancreaticoduodenecotmy(PD) is considered as the standard procedure for peri-amplullary or pancreatic head tumors. Laparoscopic pancreaticoduodenctomy(LPD) has been reported with minimal invasive advantages, such as small incision, less blood loss, less pain, et al. Further, some trials showed LPD got less morbidity and shorter length of stay. Pancreatic fistula is the major complication for pancreaticodupdenectomy and associated with numerous serious complications, suffering reoperation or sometimes death. The reported rate was 10% to 55%. A lot of modified procedure have been proposed to reduce pancreatic fistula. Omental flaps around anastomosis have been used to prevent post pancreaticoduodenectomy fistula or hemorrhage. However, the outcomes are controversy. A modified omental patch work has been used during LPD and the initial outcomes are good. This is a pilot study to evaluate the function of the modified omental patch work on decreasing the pancreatic fistula.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •. Disease of periampullary or pancreatic head tumor
- •. Age: 18 years or older
- •Distant metastases are not diagnosed preoperatively.
- •. Patients who can provide written informed consent
Exclusion Criteria
- •. Patients with severe organ disease such as cardiac disease,respiratory illness
- •. Patients with extended LPD or vessels reconstruction
- •Patients with conversion to laparotomy
- •. Patients with pregnancy
Arms & Interventions
non-omental patchwork group
omental patchwork group
Intervention: omental patchwork (Other)
Outcomes
Primary Outcomes
pancreatic fistula
Time Frame: 90 days
Incidence of pancreatic fistula grade B/C defined by ISGPF classification
Secondary Outcomes
- Mortality(90 days)
- morbidity(90 days)
- Postoperative hospital stay(90 days)
Investigators
Yi-Ping Mou
Professor
Zhejiang Provincial People's Hospital