[Treatment of peritoneal carcinomatosis using complete excision and intraperitoneal chemohyperthermia. A phase I-II study defining the best technical procedures].

OBJECTIVES: The complete or quasi complete resection of peritoneal carcinomatosis (PC) followed with IPCH is potentially able to cure some patients with a disease confined to the peritoneum. The aim of this prospective phase I-II study was to elaborate an efficient IPCH procedure with a good thermal homogeneity and a good spatial diffusion, which should be reproductible (and so standardizable and exportable), and to appreciate its tolerance and its carcinologic impact. PATIENTS AND METHODS: Seven IPCH procedures were successively tested in 32 patients (for a total of 35 IPCH); each of these were tested in at least four patients before being modified for technical or tolerance reason. Five of them were followed with an immediate postoperative intraperitoneal chemotherapy (IPIC) lasting four days. Thermal homogeneity was measured with six thermal probes situated in different places inside the abdominal cavity. Spatial diffusion was studied in the last patients by adding methylene blue in the IPCH liquid. The precise extent of the PC was reported, for each intra-abdominal region, and scored with a peritoneal index (ranging from 1 to 39). The mean follow-up was 23.85 months for the series.
RESULTS: Procedures with the closure of the abdomen were not efficient: thermal homogeneity was almost satisfactory when only the skin was closed, but these 'closed' procedures did not permit the treatment of all the risky surfaces. The peritoneal cavity 'expander' did not permit the treatment of the parietal wound, and an undetermined amount of the perfusion oozed out at its periphery. The open technique by tracking the skin upwards was the best one. Death occurred in three patients (9.4%), and complications occurred in 24 patients (75%) during the postoperative course. Intra-abdominal complications were significantly correlated (P = 0.02) with the peritoneal index (scoring the extent of the PC). The two year survival rate was 60%, and PC did not recur in 50% of the patients.
CONCLUSION: An efficient and reproducible procedure for IPCH was defined: an open procedure with an upwards traction of the skin. The post-IPCH IPIC was abandoned because it did not treat all the risky peritoneal surfaces. Patients with an extended PC and with extraperitoneal localization did not seem to have benefited from this therapeutic approach. Progress is needed in the chemotherapeutical procedure and indications must be more finely defined.

RCT Entities:   Population Interventions Outcomes