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A clinical trail to study the effect of stenting vs direct surgery in patients with obstructive jaundice secondary to periampullary or pancreatic tumor

Preoperative Biliary Drainage and surgery Versus Early Surgery in Obstructive Jaundice due to Periampullary and Pancreatic head tumor : A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/003980
Enrollment
280
Registered
2013-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- patient with surgical obstructive jaundice secondary to periampullary or pancreatic tumor with good functional status ( ECOG 0,1,2)

Interventions

Intervention1: STENTING: stenting will be done followed by surgery after 4 weeks once the bilirubin level falls below 5 mg% Control Intervention1: surgery: surgery will be done with bilirubin 10 to 20

Sponsors

None listed

Eligibility

Inclusion criteria

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 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

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

Design outcomes

Primary

MeasureTime frame
post op mortality and morbidityTimepoint: post op mortality and morbidity

Secondary

MeasureTime frame
quality of life survival procedure related complicationTimepoint: till survival

Countries

India

Contacts

Public ContactDrPeush Sahni

AIIMS

peush_sahni@hotmail.com01126593461

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026