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surgery and intra abdominal chemotherapy for stage 4 gall bladder cancer

CRS -HIPEC for gall bladder carcinoma with limited peritoneal metastases : A pilot study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042338
Enrollment
30
Registered
2022-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: C23- Malignant neoplasm of gallbladder

Interventions

Intervention1: CRS and HIPEC: cytoreductive surgery( radical cholecystectomy, peritonectomy and adjacent organ resection if required) with HIPEC using Gemcitabine Control Intervention1: NA: NA

Sponsors

Rajiv Gandhi Cancer Institute and research centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age : 18-65 years 2. ECOG : 0-1 3. All patients of gall bladder carcinoma with synchronous isolated peritoneal metastases 4. PCI

Exclusion criteria

Exclusion criteria: 1. Poor performance status(ECOG 2 and above) 2. Liver , lung, left paraaortic or other distant metastases excluding IAC lymph node metastases 3. Recurrent Disease 4. Locally unresectable disease 5. Requirement of major hepatectomy or HPD for R0 resection 6. Rare histology - NEC, sarcoma. 7. Significant medical comorbidity ââ?¬â?? Contraindication to chemotherapy 8. Progressive or stable disease on neoadjuvant CT 9. CKD 10. CLD 11. Not giving consent

Design outcomes

Primary

MeasureTime frame
CRS and HIPEC may improve diseases free and overall survival in patients with ca GB and peritoneal metastasesTimepoint: status of the patient will be assessed every 3 months after surgery for disease recurrence or death .

Secondary

MeasureTime frame
Complication rate of CRS and HIPECTimepoint: Post operative period upto 30 days

Countries

India

Contacts

Public ContactDr Shivendra Singh

Rajiv Gandhi Cancer Institute and research centre

shiven_24@yahoo.co.in01147022052

Outcome results

None listed

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