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A Modified Omental Patch Work Decreases Pancreatic Fistula After Lpd

A Modified Omental Patch Work Decreases Pancreatic Fistula After Laparoscopic Pancreaticoduodenectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04704882
Enrollment
162
Registered
2021-01-12
Start date
2021-01-01
Completion date
2022-05-31
Last updated
2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Pancreaticoduodenectomy, Omental Patch, Pancreatic Fistula

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.

Interventions

OTHERomental patchwork

the omental flaps were sewn to lesser omentum and hepatorenal ligament to cover all the vessels

Sponsors

Zhejiang Provincial People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. . Disease of periampullary or pancreatic head tumor 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 extended LPD or vessels reconstruction 3. Patients with conversion to laparotomy 4. . Patients with pregnancy

Design outcomes

Primary

MeasureTime frameDescription
pancreatic fistula90 daysIncidence of pancreatic fistula grade B/C defined by ISGPF classification

Secondary

MeasureTime frame
morbidity90 days
Mortality90 days
Postoperative hospital stay90 days

Countries

China

Contacts

Primary Contactping yi mou, doctor
yipingmou@126.com+8613605818289

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026