A Modified Omental Patch Work Decreases Pancreatic Fistula After Lpd

Pancreatic Fistula Clinical Trial

Official title:

A Modified Omental Patch Work Decreases Pancreatic Fistula After Laparoscopic Pancreaticoduodenectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04704882
• Other study ID #: ZJPPHGIP-RCT2019001
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: December 2021
• Source: Zhejiang Provincial People's Hospital
• Contact: ping yi mou, doctor
• Phone: +8613605818289
• Email: yipingmou[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Laparoscopic Pancreaticoduodenectomy
• Omental Patch
• Pancreatic Fistula

Intervention

Other:
• omental patchwork
the omental flaps were sewn to lesser omentum and hepatorenal ligament to cover all the vessels

Locations

Country	Name	City	State
China	Zhejiang Provincial People'S Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pancreatic fistula	Incidence of pancreatic fistula grade B/C defined by ISGPF classification	90 days
Secondary	morbidity		90 days
Secondary	Mortality		90 days
Secondary	Postoperative hospital stay		90 days