OBJECTIVE:Clinical efficacy of B-ultrasound-guided and laparoscopy-assisted continuous hyperthermic intraperitoneal perfusion chemotherapy (CHIPC) for treatment of malignant ascites was investigated. METHODS:Sixty-two patients with malignant ascites induced by ovarian or gastrointestinal cancers were randomly treated with B-ultrasound-guided CHIPC (therapeutic group) or laparoscopy-assisted CHIPC (control group) performed at the same center. Hospitalization costs and surgical duration were evaluated. Follow-up was conducted for 21 months with B-ultrasound or computed tomography at least once per month for assessment of ascites amount and tumor progression. Clinical efficacy was assessed by modified World Health Organization criteria. Survival time, Karnofsky performance score (KPS) of quality of life (QOL), and complications were recorded for all patients. RESULTS:Overall condition, primary disease type, and ascites amounts were comparable between groups. Significantly shorter mean duration of perfusion catheter placement (35 vs. 85 min) and mean hospitalization cost (36,000 vs. 55,000 ¥/patient) were observed in the therapeutic group than the control group (P < 0.01). Significantly different KPS scores were not observed before or after CHIPC (23.13 vs. 22.64 %) in both groups (P > 0.05). No significant differences in objective remission rates of malignant ascites (93.75 vs. 93.34 %), median survival times (9 vs. 8 months), or stamp hole metastasis rates (18.75 vs. 18.15 %) were observed between groups (P > 0.05). CONCLUSIONS:B-ultrasound-guided and laparoscopy-assisted CHIPC have similar clinical efficacy for improving QOL and prolonging patient survival. B-ultrasound-guided CHIPC may, however, shorten operation times and reduce hospitalization costs, making the treatment available to a broader patient population, although port hole metastasis remains an issue.
RCT Entities:
OBJECTIVE: Clinical efficacy of B-ultrasound-guided and laparoscopy-assisted continuous hyperthermic intraperitoneal perfusion chemotherapy (CHIPC) for treatment of malignant ascites was investigated. METHODS: Sixty-two patients with malignant ascites induced by ovarian or gastrointestinal cancers were randomly treated with B-ultrasound-guided CHIPC (therapeutic group) or laparoscopy-assisted CHIPC (control group) performed at the same center. Hospitalization costs and surgical duration were evaluated. Follow-up was conducted for 21 months with B-ultrasound or computed tomography at least once per month for assessment of ascites amount and tumor progression. Clinical efficacy was assessed by modified World Health Organization criteria. Survival time, Karnofsky performance score (KPS) of quality of life (QOL), and complications were recorded for all patients. RESULTS: Overall condition, primary disease type, and ascites amounts were comparable between groups. Significantly shorter mean duration of perfusion catheter placement (35 vs. 85 min) and mean hospitalization cost (36,000 vs. 55,000 ¥/patient) were observed in the therapeutic group than the control group (P < 0.01). Significantly different KPS scores were not observed before or after CHIPC (23.13 vs. 22.64 %) in both groups (P > 0.05). No significant differences in objective remission rates of malignant ascites (93.75 vs. 93.34 %), median survival times (9 vs. 8 months), or stamp hole metastasis rates (18.75 vs. 18.15 %) were observed between groups (P > 0.05). CONCLUSIONS: B-ultrasound-guided and laparoscopy-assisted CHIPC have similar clinical efficacy for improving QOL and prolonging patient survival. B-ultrasound-guided CHIPC may, however, shorten operation times and reduce hospitalization costs, making the treatment available to a broader patient population, although port hole metastasis remains an issue.
Authors: E Facchiano; S Scaringi; R Kianmanesh; J M Sabate; B Castel; Y Flamant; B Coffin; S Msika Journal: Eur J Surg Oncol Date: 2007-07-20 Impact factor: 4.424