Octreotide drug compared with diet Restriction in treating Chyle Leak in Head and Neck Cancer Patients
Phase 3
- Conditions
- Health Condition 1: C760- Malignant neoplasm of head, face and neck
- Registration Number
- CTRI/2024/03/063582
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Head and neck cancer patients with neck dissection developing chyle leak in postoperative period as per clinical assessment milky white drain fluid or biochemical analysis
-Eastern Cooperation Oncology Group performance status 0 to 2
Exclusion Criteria
-Those patients who are considered unfit for the surgery in view of
-Abnormal Renal Liver function
-Uncontrolled DM, HTN more than or equal to 140 by 90 mmHg after appropriate medication
-Cardiac abnormality- Ischemic heart disease Ejection fraction less than 50 percent
-Any past history of gastric or duodenal ulcer
-Allergic to Octreotide
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of chyle fistula closure Date of randomization to drain output less or equal to 10 mlTimepoint: 7 days
- Secondary Outcome Measures
Name Time Method -Mean drain output in the two groups <br/ ><br>-Neck infection <br/ ><br>-Other intervention if needed Surgery IR TPN <br/ ><br>Timepoint: 60 months