PURPOSE: As a step to large-scale clinical trials, we conducted a small-scale exploratory study to clarify whether the secondary lumen of the double-lumen (DL) peripherally inserted central catheters (PICCs) could perform as well as the secondary lumen of the DL centrally inserted central catheters (CICCs), with an acceptable complication rate in the perioperative surgery period. METHODS:Forty thoracic esophageal cancer patients requiring central venous catheterization during the perioperative period were assigned to the DL-PICC (4.5-French, 60-cm) group or the DL-CICC (16-gauge, 30-cm) group, with 1:1 randomization. The primary endpoint was the completion rate of continuous catecholamine infusion via the secondary lumen during the observation period. RESULTS: Thirty-two cases (14 cases in the PICC group and 18 cases in the CICC group) were analyzed. Continuous catecholamine infusion via the secondary lumen was completed in all 32 cases. No major complications related to PICC/CICC placement/maintenance were noted in the groups during the median observation period of 6 days. CONCLUSIONS: The secondary lumen of the DL-PICCs performed as well as the secondary lumen of the DL-CICCs with acceptable safety during the relatively short perioperative period of these thoracic esophageal cancer patients (UMIN Clinical Trial Registry UMIN000008131).
RCT Entities:
PURPOSE: As a step to large-scale clinical trials, we conducted a small-scale exploratory study to clarify whether the secondary lumen of the double-lumen (DL) peripherally inserted central catheters (PICCs) could perform as well as the secondary lumen of the DL centrally inserted central catheters (CICCs), with an acceptable complication rate in the perioperative surgery period. METHODS: Forty thoracic esophageal cancerpatients requiring central venous catheterization during the perioperative period were assigned to the DL-PICC (4.5-French, 60-cm) group or the DL-CICC (16-gauge, 30-cm) group, with 1:1 randomization. The primary endpoint was the completion rate of continuous catecholamine infusion via the secondary lumen during the observation period. RESULTS: Thirty-two cases (14 cases in the PICC group and 18 cases in the CICC group) were analyzed. Continuous catecholamine infusion via the secondary lumen was completed in all 32 cases. No major complications related to PICC/CICC placement/maintenance were noted in the groups during the median observation period of 6 days. CONCLUSIONS: The secondary lumen of the DL-PICCs performed as well as the secondary lumen of the DL-CICCs with acceptable safety during the relatively short perioperative period of these thoracic esophageal cancerpatients (UMIN Clinical Trial Registry UMIN000008131).