Back to resultsA Modified Omental Patch Work Decreases Pancreatic Fistula After Lpd
Primary Purpose
Omental Patch, Laparoscopic Pancreaticoduodenectomy, Pancreatic Fistula
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
omental patchwork
Sponsored by
About this trial
This is an interventional prevention trial for Omental Patch
Eligibility Criteria
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
Sites / Locations
- Zhejiang Provincial People'S HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
omental patchwork group
non-omental patchwork group
Arm Description
Outcomes
Primary Outcome Measures
pancreatic fistula
Incidence of pancreatic fistula grade B/C defined by ISGPF classification
Secondary Outcome Measures
morbidity
Mortality
Postoperative hospital stay
Full Information
NCT ID
NCT04704882
First Posted
January 4, 2021
Last Updated
December 7, 2021
Sponsor
Zhejiang Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04704882
Brief Title
A Modified Omental Patch Work Decreases Pancreatic Fistula After Lpd
Official Title
A Modified Omental Patch Work Decreases Pancreatic Fistula After Laparoscopic Pancreaticoduodenectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Omental Patch, Laparoscopic Pancreaticoduodenectomy, Pancreatic Fistula
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
omental patchwork group
Arm Type
Experimental
Arm Title
non-omental patchwork group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
omental patchwork
Intervention Description
the omental flaps were sewn to lesser omentum and hepatorenal ligament to cover all the vessels
Primary Outcome Measure Information:
Title
pancreatic fistula
Description
Incidence of pancreatic fistula grade B/C defined by ISGPF classification
Time Frame
90 days
Secondary Outcome Measure Information:
Title
morbidity
Time Frame
90 days
Title
Mortality
Time Frame
90 days
Title
Postoperative hospital stay
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ping yi mou, doctor
Phone
+8613605818289
Email
yipingmou@126.com
Facility Information:
Facility Name
Zhejiang Provincial People'S Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
314000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tao xia, doctor
Phone
+8618653268206
Email
xiatao13@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Modified Omental Patch Work Decreases Pancreatic Fistula After Lpd
We'll reach out to this number within 24 hrs