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IRCT201107257112N1 IRCT 2011-10-03 Liver and Gastrointestinal Diseases Research Center The role of intra-abdominal chemotherapy in inoperable gastric cancer to change to operable tumor no The role of intra-abdominal chemotherapy in inoperable gastric cancer to change to operable tumor in case-control study about one year survival and improve quality of life 2011-09-16 anticipated 40 Complete https://irct.ir/trial/7538 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other. N/A Gastric cancer. Intervention 1: Intervention group: a peritoneal dialysis catheter is inserted to around the adherence area and its distal is brought out the skin. 10 days after the operation, mitomycin -cisplatin-5 Fluorouacil will be injected from the catheter during for three consecutive days using infusion pump and then the patients will be discharged. 10 days later the laparotomy will be done to explore feasibility of removing tumor. Intervention 2: Control group: The abdomen will be closed without any intervention or receiving peritoneal chemotherapy.
public Dr. Ramin Azhough
General surgery ward, Emam reza hospital, Golghasht avenue, Azadi avenue,Tabriz
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 1334 1317 azhoughr@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Shahryar Hashemzade
General surgery ward,Emam reza hospital,Golghasht avenue,Azadi avenue,Tabriz
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 1334 1317 Hashemzadesh@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: presence of criteria for diagnosis as inoperable patient including: 1-local invasion to retroperitoneal organs including: Great veins like aorta-celiac body and solid organs like pancraces. 2 - peritoneal or omentum seeding or metastatic tumor like krukenberg tumor Exclusion criteria: presence of ascites or metastasis, old age (more than 65 years old), cachectic patients with albumin less than 3 and edema no limit no limit Both C16 Malignant neoplasm of stomach Treatment - Other Other Intervention group: a peritoneal dialysis catheter is inserted to around the adherence area and its distal is brought out the skin. 10 days after the operation, mitomycin -cisplatin-5 Fluorouacil will be injected from the catheter during for three consecutive days using infusion pump and then the patients will be discharged. 10 days later the laparotomy will be done to explore feasibility of removing tumor. Control group: The abdomen will be closed without any intervention or receiving peritoneal chemotherapy. One year survival. Timepoint: 6 months after the end of trial. Method of measurement: Follow up the patients. Quality of life. Timepoint: 6 months after the end of trial. Method of measurement: Follow up the patients. Tumor perforation. Timepoint: Beginning of trial to 6 months after trial. Method of measurement: Follow the patients and study quality of patient`s life. Great vesseles perforation. Timepoint: Beginning of trial to 6 months after trial. Method of measurement: Follow the patients and study quality of patient’s life. Vomitting. Timepoint: Beginning of trial to 6 months after trial. Method of measurement: Follow the patients and study quality of patient’s life. Nausea. Timepoint: Beginning of trial to 6 months after trial. Method of measurement: Follow the patients and study quality of patient`s life. Intra abdominal infection. Timepoint: Beginning of trial to 6 months after trial. Method of measurement: Follow the patients and study quality of patient’s life. Liver and Gastrointestinal Diseases Research Center Approved 2011-06-12 Tabriz University Of Medical Sciences Tabriz University Of Medical Sciences, Golgasht avenue,Tabriz Tabriz Iran (Islamic Republic of)