Status:
ENROLLING_BY_INVITATION
Modified vs Conventional Blumgart Anastomosis of LPD for the Effects of Pancreatic Fistula of Periampullary Carcinoma
Lead Sponsor:
Affiliated Hospital of Guangdong Medical University
Conditions:
Ampullary Cancer
Bile Duct Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
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 onl...
Detailed Description
This study intends to use a prospective randomized controlled trial, the LPD patients with traditional Blumgart anastomosis as the control group, design the LPD patients with modified Blumgart anastom...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06076252
Start Date
July 1 2023
End Date
August 31 2028
Last Update
October 10 2023
Active Locations (1)
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1
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China