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Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy

NCT03767959 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 960

Last updated 2020-03-04

No results posted yet for this study

Summary

To date, pancreaticoduodenectomy (PD) is the only recognized potentially curative therapy for malignant neoplasms located in the peri-ampullary region, and is increasingly being used for the treatment of cancer through the resection of the premalignant precursors for invasive carcinomas.Postoperative pancreatic fistula (POPF) is one of the most common complications associated with substantial clinical implications following PD, which significantly affects mortality rate, length of hospital stay, and overall hospital costs. Therefore, the prevention of POPF has always been a high priority for our group as well as other international surgical groups. In 1995, investigators' group established the Chen's U-stitch approach, which was a new technique of end-to-end invaginated pancreaticojejunostomy with transpancreatic transverse U-sutures after PD, and the preliminary results were quite encouraging at that time. Thus, investigators intend to conduct a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the effect and safety of the new technique.

Conditions

  • Pancreaticoduodenectomy

Interventions

PROCEDURE

Chen's U-Suture

Chen's U-Suture is a new technique of the invaginated end-to-end pancreaticojejunostomy with transpancreatic transverse U-sutures

PROCEDURE

Classic pancreatic duct to mucosa

A Classical anastomosis technique for Pancreaticojejunostomy

Sponsors & Collaborators

  • Chen Xiaoping

    lead OTHER

Principal Investigators

  • Xiaoping Chen · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2021-06-30
Completion
2021-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03767959 on ClinicalTrials.gov