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

NCT06076252 | Enrolling By Invitation DMC

• 1 other identifier: PJKT2023-061
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ampullary Cancer; Bile Duct Cancer; Pancreas Cancer; Duodenum Cancer

Outcome Measures

Primary Outcomes (1)

• The rate of POPF

  The rate of Postoperative pancreatic fistula

  90 Days after surgery

Study Arms (2)

Modified Blumgart Anastomosis of LPD

EXPERIMENTAL

The effect of modified Blumgart technique in the treatment of periampulltrary carcinoma on postoperative pancreatic fistula

Procedure: Modified Blumgart Anastomosis in LPD

Conventional Blumgart Anastomosis of LPD

OTHER

The effect of Conventional Blumgart Anastomosis in the treatment of periampulltrary carcinoma on postoperative pancreatic fistula

Procedure: conventional Blumgart anastomosis in LPD

Interventions

Modified Blumgart Anastomosis in LPD PROCEDURE

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

Modified Blumgart Anastomosis of LPD

conventional Blumgart anastomosis in LPD PROCEDURE

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

Conventional Blumgart Anastomosis of LPD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radically resectable stage I - III low periampullary carcinoma in patients, And all met the following criteria:
• age 18-75 years;
• imaging (upper abdominal MRI, MRCP / CT / CTA) diagnosis of periampullary (duodenal papilla, ampulla, inferior common bile duct, pancreatic head);
• MDT discussion of tumor invasion of large vessels (SMA, CA, CHA/SMV, PV) resectable;
• endoscopic duodenal ultrasound diagnosis of periampullary carcinoma;
• endoscopic biopsy pathology confirmation of carcinoma (not essential);
• preoperative stage within T3N1;
• no evidence of distant metastasis;
• cardiopulmonary and liver and kidney function can tolerate surgery;
• patients and family members can understand and willing to participate in this study, Provided the written informed consent.

You may not qualify if:

• Diagnosis of malignant tumors in other sites;
• ASA grade IV and / or ECOG physical strength status score\> 2 points;
• Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or severe basic diseases who cannot tolerate surgery;
• Have an uncontrolled preoperative infection;
• Pregnant or lactating women;
• A history of serious mental illness;
• Patients with other clinical and laboratory conditions considered by the investigator are not suitable to participate in this trial

Sponsors & Collaborators

• Affiliated Hospital of Guangdong Medical University: lead

Study Sites (1)

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Location

MeSH Terms

Conditions

Bile Duct Neoplasms; Pancreatic Neoplasms; Duodenal Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases

Study Officials

• Liu Guohua

  Affiliated Hospital of Guangdong Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: October 10, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)