The American Journal of GASTROENTEROLOGY VOLUME 106 | SEPTEMBER 2011 www.amjgastro.com ORIGINAL CONTRIBUTIONS nature publishing group 1612 ESOPHAGUS see related editorial on page x INTRODUCTION Esophageal cancer has a very poor prognosis. Despite recent progress in diagnostic and therapeutic methods, only about 10% of patients can be cured. Palliative therapy aimed at relieving dysphagia is used in a majority of patients. If therapy is successful in restoring natural feeding, it signiicantly improves quality of life (QoL). Randomized Comparison of Three Palliative Regimens Including Brachytherapy, Photodynamic Therapy, and APC in Patients With Malignant Dysphagia (CONSORT 1a) (Revised II) Maciej Rupinski, MD 1 , Edyta Zagorowicz, MD 1 , Jaroslaw Regula, MD 1 , Jacek Fijuth, MD 2 , Ewa Kraszewska, MSc 1 , Marcin Polkowski, MD 1 , Ewa Wronska, MD 1 and Eugeniusz Butruk, MD 1 OBJECTIVES: Because most esophageal cancers are diagnosed at an advanced stage, a majority of patients require palliative dysphagia treatment. Dysphagia severity and the need for repeated re-canalization procedures significantly affect patients’ quality of life (QoL). The aim of this study was to establish whether combining argon plasma coagulation (APC) of the neoplastic esophageal tissue with another re-canalization method results in a longer dysphagia-free period compared with APC alone. METHODS: We conducted a randomized trial in 93 patients with malignant dysphagia. Patients were followed until death. We compared three regimens of esophageal re-canalization; APC combined with high dose rate (HDR) brachytherapy, APC combined with photodynamic therapy (PDT), and APC alone. The primary outcome measure was the dysphagia-free period following randomization. Secondary measures were survival, QoL, treatment-associated complications, and treatment tolerance. A per-protocol analysis was carried out. RESULTS: The time to first dysphagia recurrence was significantly different between each combination treatment group and the control group (overall test: P = 0.006; HDR vs. control, log-rank P = 0.002, PDT vs. control, log-rank P = 0.036), but not different between the combination groups (HDR vs. PDT, log-rank P = 0.36). The median time to first dysphagia recurrence was 88, 59, and 35 days in the HDR, PDT, and control groups, respectively. There was no difference in overall survival between the study groups ( P = 0.27). No deaths, perforations, hemorrhages, or fistula formations were attributed to treatment. The only major complication was fever, occurring in three PDT patients. Minor complications were observed significantly more often in the combination treatment groups and included pain in both groups, transient dysphagia worsening, and skin sensitivity in the PDT group. The QoL 30 days after treatment in the HDR group was significantly better than in the other groups. CONCLUSIONS: In patients with inoperable esophageal cancer, palliative combination treatment of dysphagia with APC and HDR or PDT was significantly more efficient than APC alone, and was safe and well tolerated. APC combined with HDR resulted in fewer complications and better QoL than APC with PDT or APC alone (CONSORT 1b). SUPPLEMENTARY MATERIAL is linked to the online version of the paper at http://www.nature.com/ajg Am J Gastroenterol 2011; 106:1612–1620; doi:10.1038/ajg.2011.178; published online 14 June 2011 1 Gastroenterology Department, Medical Center for Postgraduate Education and Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology , Warsaw, Poland; 2 Radiotherapy Department, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology , Warsaw , Poland. Correspondence: Edyta Zagorowicz, MD, Gastroenterology Department, Medical Center for Postgraduate Education and Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology , 5 Roentgen Street, 02-781 Warsaw , Poland. E-mail: ezagorowicz@wp.pl Received 22 July 2010; accepted 15 February 2011