Clinical study to know the role of PET CT in assessing response to chemoradiotherapy prior to surgery and assessment of distant spread in carcinoma gallbladder
- Conditions
- Health Condition 1: null- carcinoma gallbladder
- Registration Number
- CTRI/2014/03/004500
- Lead Sponsor
- not applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 40
•All patients with gall bladder cancer, who are being administered neoadjuvant therapy.
•All patients with gallbladder cancer who are being planned for surgery.
•All patients with incidentally detected carcinoma gallbladder who are being planned for surgery.
•Ability to understand and willingness to sign a written informed consent
a)Patient refuses consent.
b)Poor performance status (ECOG â?? 3 and 4)
c) Major co-morbid conditions such as cirrhosis, renal failure, uncontrolled hypertension or cardiac failure .
d)Patients who have received chemotherapy/ radiotherapy within 12 months prior to study entry.
e) Any evidence of metastasis to distant organs (liver, lung, peritoneum,brain, bone etc).
f) Non-contiguous liver metastasis (M1 disease).
g) Major vascular involvement such as proper hepatic artery involvement and main portal vein involvement (T4 â?? inoperable disease).
h) Periaortic, Pericaval, Superior mesenteric artery and/or Celiac artery lymph node involvement (N2 disease) â?? confirmed by
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)To compare PET-CT, conventional imaging and histopathology in assessing response to neoadjuvant therapy in carcinoma gallbladder <br/ ><br>2)To assess distant metastasis using preoperative PET-CT and correlate this with conventional imaging, laparoscopic staging, histopathology and intraoperative findingsTimepoint: 1 year 9 months
- Secondary Outcome Measures
Name Time Method To assess distant metastasis using preoperative PET-CT and correlate this with conventional imaging, laparoscopic staging, histopathology and intraoperative findingsTimepoint: 1 year 9 months