A clinical trial to study the effects of two surgical modalities of treatment, open pancreatoduodenectomy and laparoscopic pancreatoduodenectomy in patients with periampullary and pancreatic head cancers.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Resectable Periampullary malignant conditions like carcinoma of1.Head of Pancreas2.Duodenum 3.Lower end cholangiocarcinoma 4.Ampulla
- Registration Number
- CTRI/2013/09/004016
- Lead Sponsor
- Gem Hospital Research Centre Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Adult males or females with a diagnosis of either of resectable Periampullary cancers.
Resectability in Periampullary cancer is defined radio logically as:
1.No evidence of metastasis
2.Radiological non-involvement of SMV & PV
3.Preserved fat planes between celiac axis, HA & SMA
Exclusion Criteria
1.Unresectable Tumor at surgery
2.Pancreatoduodenectomy with portal vein resection
3.Pancreatoduodenectomy for other diagnosis like cystic tumors or CCP with head mass
4.With prior Neoadjuvant treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Complications according to the expanded Accordion Severity Grading System <br/ ><br>2.Overall Outcome <br/ ><br>Timepoint: 1. Discharge from hospital or death <br/ ><br>2. Follow up at 6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Blood Loss <br/ ><br>2.Operating Time <br/ ><br>3.No of LN retrieved <br/ ><br>4.Hospital Stay <br/ ><br>5.Follow Up upto 6 months <br/ ><br>Timepoint: 6 months