A Modified Omental Patch Work Decreases Pancreatic Fistula After Lpd

• Sponsor: Zhejiang Provincial People's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04704882
• Collaborator: (none)
• Enrollment: 162
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16.9
• Patients Per Site Per Month: 9.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Omental Patch; Laparoscopic Pancreaticoduodenectomy; Pancreatic Fistula	Other: omental patchwork	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: A Modified Omental Patch Work Decreases Pancreatic Fistula After Laparoscopic Pancreaticoduodenectomy
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: May 31, 2022
• Anticipated Study Completion Date: May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: omental patchwork group	Other: omental patchwork; the omental flaps were sewn to lesser omentum and hepatorenal ligament to cover all the vessels
No Intervention: non-omental patchwork group

Outcome Measures

Primary Outcome Measures

1. pancreatic fistula [90 days]

   Incidence of pancreatic fistula grade B/C defined by ISGPF classification

Secondary Outcome Measures

1. morbidity [90 days]

2. Mortality [90 days]

3. Postoperative hospital stay [90 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Provincial People'S Hospital	Hangzhou	Zhejiang	China	314000

Sponsors and Collaborators

• Zhejiang Provincial People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yi-Ping Mou, Professor, Zhejiang Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT04704882
• Other Study ID Numbers: ZJPPHGIP-RCT2019001
• First Posted: Jan 12, 2021
• Last Update Posted: Dec 8, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Fistula; Fistula

Study Results

No Results Posted as of Dec 8, 2021