A Modified Omental Patch Work Decreases Pancreatic Fistula After Lpd
1 other identifier
interventional
162
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 4, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedDecember 8, 2021
December 1, 2021
1.4 years
January 4, 2021
December 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
pancreatic fistula
Incidence of pancreatic fistula grade B/C defined by ISGPF classification
90 days
Secondary Outcomes (3)
morbidity
90 days
Mortality
90 days
Postoperative hospital stay
90 days
Study Arms (2)
omental patchwork group
EXPERIMENTALnon-omental patchwork group
NO INTERVENTIONInterventions
the omental flaps were sewn to lesser omentum and hepatorenal ligament to cover all the vessels
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang Provincial People'S Hospital
Hangzhou, Zhejiang, 314000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 4, 2021
First Posted
January 12, 2021
Study Start
January 1, 2021
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
December 8, 2021
Record last verified: 2021-12