MedDataX Logo

A Modified Omental Patch Work Decreases Pancreatic Fistula After Lpd

NCT ID: NCT04704882

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Omental Patch Laparoscopic Pancreaticoduodenectomy Pancreatic Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

omental patchwork group

Group Type EXPERIMENTAL

omental patchwork

Intervention Type OTHER

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

non-omental patchwork group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

omental patchwork

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yi-Ping Mou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhejiang Provincial People'S Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

ping yi mou, doctor

Role: CONTACT

Phone: +8613605818289

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

tao xia, doctor

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZJPPHGIP-RCT2019001

Identifier Type: -

Identifier Source: org_study_id