Health Condition 1: K66- Other disorders of peritoneum
Conditions
Interventions
Intervention1: Nanosol with Accessories
(Accessory: Nanowand): All adult patients with peritoneal metastasis of ovarian, colorectal, and gastric cancer
pseudomyxoma peritonei or mesothelioma, who are not candidates for cytoreductive surgery.
The probe used in the NAC is called Nanowand. It converts chemotherapy solutions into aerosols by generating
Sponsors
Curotherm Techno Solutions LLP
Specialty Surgical Oncology Hospital and Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18-75 years 2. ECOG performance status 2 or less than 2, ASA 1 or 2 3. Debilitating ascites 4. Extensive disease not amenable for resection 5. Not tolerating systemic chemotherapy or progressing on multiple lines of IV chemotherapy 6. Nutritionally debilitated because of extensive disease
Exclusion criteria
Exclusion criteria: 1. Patient refusing to consent 2. Patients with distant organ metastases like liver and lung metastases, extra abdominal metastasis 3. Patients not fit for laparoscopy 4. Patients with small or large bowel obstruction/perforation or fistula 5. Patients with active infection or other concurrent medical condition that could interfere in the ability of patients to receive the proposed treatment according to protocol 6. Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones 7. A history of allergic reaction to platinum containing compounds or doxorubicin 8. Renal impairment, defined as glomerular filtration rate (GFR) than 40 mL/min 9. Impaired liver function defined as bilirubin >= 1.5 Ã? UNL (upper normal limit) and transaminases above the upper limit of normal range 10. ASA III and above (ASA grade III: A patient with a severe systemic disease that is not life-threatening)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome of the study is to assess and record the adverse events during and after the NAC procedure using the device Nanosol with Nanowand. 1. The anticipated adverse procedure effects are hematological toxicity, adverse effects on renal and liver functions. 2. The anticipated adverse device effects are infection, internal bleeding and damage to tissue/organ. Timepoint: The follow-up of the subjects will be conducted for 1 month from the date of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Praveen Kammar
Specialty Surgical Oncology Hospital and Research Centre
Outcome results
None listed