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ENROLLING BY INVITATION
NCT06076252
NA

Modified vs Conventional Blumgart Anastomosis of LPD for the Effects of Pancreatic Fistula of Periampullary Carcinoma

Sponsor: Affiliated Hospital of Guangdong Medical University

View on ClinicalTrials.gov

Summary

The incidence rate and mortality rate of periampullary cancer at home and abroad both show an increasing trend, seriously affecting the health level of the people. Pancrecoduodenectomy (PD) is the only effective treatment for periampullary cancer. However, due to the complex technology and difficulty of PD surgery, laparoscopic pancreaticoduodenectomy (LPD) is more difficult, and the postoperative mortality can reach 5%. The important reason is the most serious complication- -pancreatic fistula. The occurrence of pancreatic fistula is related to many factors, and the most critical factor is the method and technology of pancreatico-intestinal anastomosis, so the improvement and innovation of pancreaticoco-intestinal anastomosis technology has always been a hot topic in surgical clinical research. Blumgart Pancreatic anastomosis was originally created by Professor L.H.Blumgart in the United States, and was widely used in OPD due to its low incidence of pancreatic fistula. However, the traditional Blumgart anastomosis is complicated and is not suitable for application in LPD. According to our own experience, our team simplified and improved the traditional Blumgart anastomosis to OPD, and through retrospective study, it has the advantages of reducing the incidence of pancreatic fistula. However, the application value in LPD still needs to be further discussed. Therefore, this study intends to use a prospective randomized controlled trial, using the LPD patients with traditional Blumgart pancreatecointestinal anastomosis as the control group, and the LPD patients with modified Blumgart pancreatecointestinal anastomosis as the test group, compare the clinical relevant indicators and the incidence of postoperative complications, and explore whether the application value in LPD can truly simplify the surgical procedure and ensure the lower incidence of pancreatic leakage.

Official title: Modified Blumgart vs Conventional Blumgart Anastomosis Technique in the Treatment of Periampulltrary Carcinoma on Postoperative Pancreatic Fistula: an Open, Randomized, Parallel Controlled Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-07-01

Completion Date

2028-08-31

Last Updated

2023-10-10

Healthy Volunteers

No

Interventions

PROCEDURE

Modified Blumgart Anastomosis in LPD

This study is a clinical study designed by parallel control, the test group is LPD patients with modified Blumgart anastomosis and the control group is LPD patients with conventional Blumgart anastomosis

PROCEDURE

conventional Blumgart anastomosis in LPD

This study is a clinical study designed by parallel control, the test group is LPD patients with modified Blumgart anastomosis and the control group is LPD patients with conventional Blumgart anastomosis

Locations (1)

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China