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

NCT06076252 · tracked via the Priya Life Science China tracker

Sponsor

Affiliated Hospital of Guangdong Medical University

Phase

Not applicable

Started

2023-07-01

Last updated

2023-10-10

Condition(s) studied

Ampullary CancerBile Duct CancerPancreas CancerDuodenum Cancer

Investigational drug(s) / intervention(s)

Modified Blumgart Anastomosis in LPDconventional Blumgart anastomosis in LPD

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: Radically resectable stage I - III low periampullary carcinoma in patients, And all met the following criteria: 1. age 18-75 years; 2. imaging (upper abdominal MRI, MRCP / CT / CTA) diagnosis of periampullary (duodenal papilla, ampulla, inferior common bile duct, pancreatic head); 3. MDT discussion of tumor invasion of large vessels (SMA, CA, CHA/SMV, PV) resectable; 4. endoscopic duodenal ultrasound diagnosis of periampullary carcinoma; 5. endoscopic biopsy pathology confirmation of carcinoma (not essential); 6. preoperative stage within T3N1; 7. no evidence of distant metastasis; 8. cardiopulmonary and liver and kidney function can tolerate surgery; 9. patients and family members can understand and willing to participate in this study, Provided the written informed consent. Exclusion Criteria: 1. Diagnosis of malignant tumors in other sites; 2. ASA grade IV and / or ECOG physical strength status score\> 2 points; 3. Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or severe basic diseases who cannot tolerate surgery; 4. Have an uncontrolled preoperative infection; 5. Pregnant or lactating women; 6. A history of serious mental illness; 7. Patients with other clinical and laboratory conditions considered by the investigator are not suitable to participate in this trial

Primary outcome measure(s)

The rate of POPF — 90 Days after surgery
The rate of Postoperative pancreatic fistula

Trial sites (1)

Facility	City	Region	Status
The Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06076252 on ClinicalTrials.gov ↗ ← All trials in China