Dao-Jian Gao1, Jian-Feng Yang2, Shu-Ren Ma3, Jun Wu4, Tian-Tian Wang1, Hang-Bin Jin2, Ming-Xing Xia1, Ying-Chun Zhang3, Hong-Zhang Shen2, Xin Ye1, Xiao-Feng Zhang2, Bing Hu5. 1. Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Yangpu District, Shanghai, China. 2. Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China. 3. Department of Endoscopy, General Hospital of Shenyang Military Region, Shenyang, Liaoning Province, China. 4. Department of Gastroenterology, Third Affiliated Hospital, Second Military Medical University, Jiading District, Shanghai, China. 5. Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Yangpu District, Shanghai, China; Department of Gastroenterology, Third Affiliated Hospital, Second Military Medical University, Jiading District, Shanghai, China.
Abstract
BACKGROUND AND AIMS: We sought to compare the efficacy and safety between endoscopic radiofrequency ablation (RFA) and stent placement alone in patients with unresectable extrahepatic biliary cancer (EBC). METHODS: In this randomized controlled trial, patients with locally advanced or metastatic cholangiocarcinoma (CCA) or ampullary cancer who were unsuitable for surgery were recruited from 3 tertiary centers. Eligible patients were randomly assigned to RFA plus plastic stent placement (RFA group) or plastic stent placement alone (stent placement alone group) in a 1:1 ratio. Both groups underwent 2 scheduled interventions with an interval of approximately 3 months. The primary outcome was overall survival (OS). RESULTS: Altogether, 174 participants completed the 2 index endoscopic interventions. No significant differences in baseline characteristics were noted between the 2 groups. The median OS was significantly higher in the RFA group (14.3 vs 9.2 months; hazard ratio, .488; 95% confidence interval, .351-.678; P < .001). A survival benefit was also shown in patients with CCA (13.3 vs 9.2 months; hazard ratio, .546; 95% confidence interval, .386-.771; P < .001). However, no significant between-group differences were found in jaundice control or stent patency duration. The postprocedural Karnofsky performance scores were significantly higher in the RFA group until 9 months (all P < .001). Adverse events were comparable between the 2 groups (27.6% vs 19.5%, P = .211), except for acute cholecystitis, which was more frequently observed in the RFA group (9 vs 0, P = .003). CONCLUSIONS: Compared with stent placement alone, additional RFA may improve OS and quality of life of patients with inoperable primary EBC who do not undergo systemic treatments. (Clinical trial registration number: NCT01844245.).
RCT Entities:
BACKGROUND AND AIMS: We sought to compare the efficacy and safety between endoscopic radiofrequency ablation (RFA) and stent placement alone in patients with unresectable extrahepatic biliary cancer (EBC). METHODS: In this randomized controlled trial, patients with locally advanced or metastatic cholangiocarcinoma (CCA) or ampullary cancer who were unsuitable for surgery were recruited from 3 tertiary centers. Eligible patients were randomly assigned to RFA plus plastic stent placement (RFA group) or plastic stent placement alone (stent placement alone group) in a 1:1 ratio. Both groups underwent 2 scheduled interventions with an interval of approximately 3 months. The primary outcome was overall survival (OS). RESULTS: Altogether, 174 participants completed the 2 index endoscopic interventions. No significant differences in baseline characteristics were noted between the 2 groups. The median OS was significantly higher in the RFA group (14.3 vs 9.2 months; hazard ratio, .488; 95% confidence interval, .351-.678; P < .001). A survival benefit was also shown in patients with CCA (13.3 vs 9.2 months; hazard ratio, .546; 95% confidence interval, .386-.771; P < .001). However, no significant between-group differences were found in jaundice control or stent patency duration. The postprocedural Karnofsky performance scores were significantly higher in the RFA group until 9 months (all P < .001). Adverse events were comparable between the 2 groups (27.6% vs 19.5%, P = .211), except for acute cholecystitis, which was more frequently observed in the RFA group (9 vs 0, P = .003). CONCLUSIONS: Compared with stent placement alone, additional RFA may improve OS and quality of life of patients with inoperable primary EBC who do not undergo systemic treatments. (Clinical trial registration number: NCT01844245.).
Authors: David M de Jong; Jeska A Fritzsche; Amber S Audhoe; Suzanne S L Yi; Marco J Bruno; Rogier P Voermans; Lydi M J W van Driel Journal: Cancers (Basel) Date: 2022-04-21 Impact factor: 6.639
Authors: Jana Jarosova; Peter Macinga; Lenka Krupickova; Martina Fialova; Alzbeta Hujova; Jan Mares; Ondrej Urban; Jan Hajer; Julius Spicak; Ilja Striz; Tomas Hucl Journal: Biomedicines Date: 2022-06-06