A prospective, randomized study comparing 2 techniques of pancreatoduodenectomy in pancreatic cancer with special focus on resection margins and medium term survival outcomes
Not Applicable
- Conditions
- Health Condition 1: null- Patients with resetable/ borderline resectable pancreatic head cancer with good performance status.
- Registration Number
- CTRI/2013/10/004045
- Lead Sponsor
- ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
1.Good performance status (Eastern Cooperative Oncology Group performance status 0, 1, 2)
2.Age: 18-75 years
3.Patients with a diagnosis of
i)Resectable carcinoma head of pancreas
ii) Resectable periampullary tumors
iii)Patients with borderline resectability (for both tumor categories) will also be included in both arms.
Exclusion Criteria
1.Patient unwilling to consent for the study
2.Metastatic or unresectable disease
3.Patient undergoing total pancreatectomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome <br/ ><br>1.R0 resection rate in the 2 arms (LEEDS Protocol). <br/ ><br>2. Number of lymph nodes harvested. <br/ ><br>Timepoint: Patient accrual: 1.5-2 years <br/ ><br>Follow up: at least 6 months post resection <br/ ><br>Prospective clinical and path data collection <br/ ><br>Interim analysis at 2 years
- Secondary Outcome Measures
Name Time Method 1.Operative time <br/ ><br>2.Incidence of postoperative complications. <br/ ><br>3.Recurrence-free and overall survival.Timepoint: Prospective data collection <br/ ><br>Minimum follow up of 6 months <br/ ><br>Maximum follow up till disease recurrence/death