Endoscopic balloon dilation with steroid injection versus radial incision and cutting with steroid injection for refractory esophageal anastomotic stricture: a randomized study

Esophageal stricture causes severe distress to patients; however, there are no established treatments for esophageal anastomotic strictures refractory to endoscopic balloon dilation (EBD). Steroid injection added to EBD and radial incision and cutting (RIC) are effective for such strictures, but it is unclear which is more effective. The objective of this study was to investigate the safety and efficacy of RIC plus steroid injection compared with EBD plus steroid injection for patients with refractory anastomotic strictures after esophagectomy.This was a multicenter, randomized phase II/III trial. Patients with esophageal anastomotic strictures refractory to three or more dilations were eligible. The primary endpoint in phase II was the proportion of predefined grade 3/4 adverse events (AEs). The co-primary endpoints in phase III were restricture-free survival and number of EBDs in the 24 weeks after treatment.130 patients were enrolled, with a dysphagia score of grade 2 in 104 patients (80.0%). The median number of dilations before registration was five in each arm. Predefined grade 3/4 AEs occurred in two patients (3.1%) in each arm. Restricture-free survival was 10.6 weeks (95%CI 6.9-20.1 weeks) with EBD and 8.7 weeks (95%CI 7.1-10.9 weeks) with RIC (one-sided <i>P</i>=0.82). The median number of EBDs in the 24 weeks after initial treatment was one (interquartile range [IQR] 0-2) for EBD and two (IQR 0-3) for RIC (one-sided <i>P</i>=0.99).EBD combined with steroid injection is the standard treatment for refractory anastomotic stricture after esophagectomy.

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Journal
Endoscopy
Published
2025-04-08
DOI
https://doi.org/10.1055/a-2577-2119
Primary Topic
Esophageal and GI Pathology
Type
article
Field-Weighted Citation Impact
0.00

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Endoscopic balloon dilation with steroid injection versus radial incision and cutting with steroid injection for refractory esophageal anastomotic stricture: a randomized study

Yuji Urabe, Tsutomu Tanaka, Ko Nagino, Masashi Tamaoki et al.
Endoscopy
Esophageal and GI Pathology
article

Endoscopic balloon dilation with steroid injection versus radial incision and cutting with steroid injection for refractory esophageal anastomotic stricture: a randomized study

Yuji Urabe, Tsutomu Tanaka, Ko Nagino, Masashi Tamaoki, Masaaki Kobayashi, Yusuke Sano, Tomonori Yano, Seiichiro Abe, Kozo Kataoka, Yutaka Saito, Kazuya Ohno, Takeshi Setoyama, Yasuaki Nagami, Takuto Hikichi, Tomohiro Kadota, Gakuto Ogawa, Toshihiko Tomita, Ikuo Aoyama, Kohei Takizawa, Manabu Muto, Hisashi Doyama, Yoshinobu Yamamoto, Hiroyuki Ono, Shinji Nagata
article en

Abstract

Esophageal stricture causes severe distress to patients; however, there are no established treatments for esophageal anastomotic strictures refractory to endoscopic balloon dilation (EBD). Steroid injection added to EBD and radial incision and cutting (RIC) are effective for such strictures, but it is unclear which is more effective. The objective of this study was to investigate the safety and efficacy of RIC plus steroid injection compared with EBD plus steroid injection for patients with refractory anastomotic strictures after esophagectomy.This was a multicenter, randomized phase II/III trial. Patients with esophageal anastomotic strictures refractory to three or more dilations were eligible. The primary endpoint in phase II was the proportion of predefined grade 3/4 adverse events (AEs). The co-primary endpoints in phase III were restricture-free survival and number of EBDs in the 24 weeks after treatment.130 patients were enrolled, with a dysphagia score of grade 2 in 104 patients (80.0%). The median number of dilations before registration was five in each arm. Predefined grade 3/4 AEs occurred in two patients (3.1%) in each arm. Restricture-free survival was 10.6 weeks (95%CI 6.9-20.1 weeks) with EBD and 8.7 weeks (95%CI 7.1-10.9 weeks) with RIC (one-sided <i>P</i>=0.82). The median number of EBDs in the 24 weeks after initial treatment was one (interquartile range [IQR] 0-2) for EBD and two (IQR 0-3) for RIC (one-sided <i>P</i>=0.99).EBD combined with steroid injection is the standard treatment for refractory anastomotic stricture after esophagectomy.

EndoscopyVol. 57(09)
Hyogo Medical University (JP), Kyoto University (JP), Kanagawa Prefectural Hospital Organization (JP), Shizuoka Cancer Center (JP), Niigata Cancer Center Hospital (JP), Hiroshima City Asa Citizens Hospital (JP), Ishikawa Prefectural Central Hospital (JP), Osaka Hospital (JP), Hiroshima University Hospital (JP), Yamagata Prefectural Central Hospital (JP), North Medical Center (JP), Aichi Cancer Center (JP), Otsu Red Cross Hospital (JP), Shizuoka General Hospital (JP), National Cancer Center Hospital East (JP), Fukushima Medical University Hospital (JP), Japan Clinical Cancer Research Organization (JP), Osaka Red Cross Hospital (JP), Hyogo Prefectural Cancer Center (JP), Kanagawa Cancer Center, Osaka Metropolitan University (JP), Tokyo Metropolitan University (JP), Hyogo University (JP)
Japan Agency for Medical Research and Development, National Cancer Center Japan
Good health and well-being
Openalex Percentile: Top 87%
Esophageal and GI Pathology
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