Health Condition 1: C15-C26- Malignant neoplasms of digestive organs Health Condition 2: C51-C58- Malignant neoplasms of female genital organs
Conditions
Interventions
Intervention1: Minimally-invasive cytoreductive surgery followed by midline mini-laparotomy: This is a single-arm, prospective, observational/interventional study. Patients with both primary and secon
Sponsors
Society of peritoneal surface oncology India
Eligibility
Inclusion criteria
Inclusion criteria: ECOG performance status 1 or less than 1, ASA 1 or 2 • Patients with biopsy proven peritoneal malignancy that includes the following primary sites: colorectal cancer, epithelial ovarian cancer, peritoneal mesothelioma, pseudomyxoma peritonei, gastric cancer with radiological PCI is less than 10 and no sign of unresectability on imaging • Patients with advanced ovarian cancer undergoing primary or interval cytoreductive surgery will be included if the radiological PCI is less than 10 • Patients with recurrent ovarian cancer with 1-2 tumor sites will be included if MI-CRS is feasible • Laparoscopic PCI less than 10 • Age 18 years-80 years • Normal blood counts and blood biochemistry • No medical contraindication to major abdominal surgery • Patients who have had previous laparoscopic surgery for primary tumor resection will be included if all the other criteria are fulfilled • Patients with prior laparotomy could be included if the same was not performed for treating peritoneal malignancy by cytoreductive surgery except selected cases of recurrent ovarian cancer with only 1-2 sites of disease.
Exclusion criteria
Exclusion criteria: • Prior CRS with or without HIPEC • Patients with a PCI less than 10 and imaging features indicate that CC-0 or CC-1 is not possible • Patients with PCI less than 10 in whom unresectable disease is discovered at staging laparoscopy • Patients undergoing prophylactic procedures/second look procedures • Age less than 18 years or greater than 80 years • Primary tumor site excluding colorectal cancer, gastric cancer, advanced ovarian cancer, peritoneal mesothelioma and pseudomyxoma peritonei • Patient refusing consent • Renal impairment, defined as glomerular filtration rate (GFR) than 40 mL/min • Impaired liver function defined as bilirubin greater than or equal to 1.5 × UNL (upper normal limit) and transaminases above the upper limit of normal range • ASA III and above (ASA grade III: A patient with a severe systemic disease that is not life-threatening) • Patients with distant organ metastases like liver and lung metastases, extra abdominal metastasis • Patients not fit for laparoscopy • Patients with small or large bowel obstruction/perforation or fistula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with pathologically proven peritoneal disease that was not identified/resected during MI-CRSTimepoint: The primary end-point will be evaluated at the end of trial recruitment when all patients have been included | — |
Secondary
| Measure | Time frame |
|---|---|
| • Incidence of pathologically proven disease in ‘normal appearing’ target regions (greater omentum, lesser omentum, falciform ligament and/or umbilical round ligament) resected during laparotomy which were not resected during MI-CRSTimepoint: Yearly till the end of recruitment;• Duration of hospitalizationTimepoint: Yearly till the end of recruitment;• Grade 3-4 morbidity at 90 daysTimepoint: Yearly till the end of recruitement;• Perioperative outcomes : operative time • Perioperative outcomes : blood loss • Perioperative outcomes: use of opioids Timepoint: Yearly till the end of recruitment;• Recovery of bowel function (time to first flatus)Timepoint: Yearly till the end of recruitment;1 year progression-free survivalTimepoint: 1 year after the last patient has been recruited;3- year progression-free and overall survivalTimepoint: 3 years after the last patient has been recruited;5-year progression-free and overall survivalTimepoint: 5 years after the last patient has been recruited | — |
Countries
India
Contacts
Public ContactAditi Bhatt
Shalby Cancer and Research Institute
Outcome results
None listed