A clinical trail to study the effect of stenting vs direct surgery in patients with obstructive jaundice secondary to periampullary or pancreatic tumor
Not Applicable
Recruiting
- Conditions
- Health Condition 1: null- patient with surgical obstructive jaundice secondary to periampullary or pancreatic tumor with good functional status ( ECOG 0,1,2)
- Registration Number
- CTRI/2013/09/003980
- Lead Sponsor
- OT APPLICABLE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 280
Inclusion Criteria
1.Good performance status (Eastern Cooperative Oncology Group â?? performance status 0,1,2).
2.Cases of lower end tumors with obstructive jaundice.
3.Bilirubin ( >=10 mg/dl and <= 25 mg/dl ).
4.Imaging : Dual phase CT scan showing no evidence of distant metastasis, local tumor ingrowth into portal vessels or mesenteric vessels (as defined by the tumor surrounding the vessel for at least 180 degrees of the circumference)
Exclusion Criteria
1.Age >70 years
2.Presence of cholangitis/infection,renal impairment , poor nutritional status
3.Preoperative biliary drainage by any means ( surgical, endoscopic or percutaneous )
4.Previous chemotherapy
5.Gastric outlet obstruction : vomiting, nausea and/or oral intake less than one L /day
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method