Health Condition 1: C168- Malignant neoplasm of overlappingsites of stomach Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Sequential Peritoneal Lavage Cytology: Patients undergoing curative-intent gastrectomy with D2 lymphadenectomy will undergo peritoneal lavage cytology sampling at two predefined time po
Sponsors
Basavatarakam Indo American Cancer Hospital and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients 18 years or older with histologically confirmed gastric adenocarcinoma. Clinical stage cT1 T4a N0 or N positive and M0 disease based on preoperative staging. Patients planned for curative-intent gastrectomy (subtotal or total) with D2 lymphadenectomy. No evidence of peritoneal metastasis on preoperative imaging or diagnostic laparoscopy or positive peritoneal wash cytology ECOG performance status 0 2. Ability and willingness to provide written informed consent for additional peritoneal lavage sampling during surgery.
Exclusion criteria
Exclusion criteria: Visible peritoneal metastasis or carcinomatosis detected during staging laparoscopy or laparotomy. Patients undergoing emergency surgery or surgery with palliative intent. Previous abdominal surgery or radiotherapy that prevents adequate peritoneal lavage sampling. Pregnant women. Patients unable or unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with conversion of peritoneal lavage cytology from negative before tumor manipulation to positive after tumor resection, indicating intraoperative dissemination of free cancer cellsTimepoint: During surgery (comparison of pre-manipulation lavage sample and post-resection lavage sample) | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline prevalence of positive peritoneal lavage cytology before tumor manipulation.Timepoint: Intraoperative (pre-manipulation sample);Peritoneal recurrence rate in relation to cytology status.Timepoint: 12 months and 24 months follow-up.;Overall survival of patients according to cytology status.Timepoint: 24 months follow-up. | — |
Countries
India
Contacts
Public ContactSyed Nusrath
Basavatarakam Indo American Cancer Hospital and Research Institute
Outcome results
None listed