Endoscopy 2025; 57(09): 980-989
DOI: 10.1055/a-2577-2119
Original article

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

Ikuo Aoyama
1   Department of Gastroenterology, Japanese Red Cross Otsu Hospital, Otsu, Japan (Ringgold ID: RIN26775)
2   Department of Medical Oncology, Kyoto University Graduate School of Medicine Faculty of Medicine, Kyoto, Japan (Ringgold ID: RIN38049)
,
Kohei Takizawa
3   Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan (Ringgold ID: RIN91321)
,
Kozo Kataoka
4   Department of Gastroenterological Surgery, Hyogo Medical University, Nishinomiya, Japan (Ringgold ID: RIN12818)
,
Gakuto Ogawa
5   Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan (Ringgold ID: RIN68380)
,
Yusuke Sano
5   Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan (Ringgold ID: RIN68380)
,
6   Department of Gastrointestinal Oncology, Hyogo Cancer Center, Akashi, Japan (Ringgold ID: RIN13794)
,
Tsutomu Tanaka
7   Department of Endoscopy, Aichi Cancer Center Hospital, Nagoya, Japan (Ringgold ID: RIN538363)
,
Takeshi Setoyama
8   Department of Gastroenterology, Japan Red Cross Osaka Hospital, Osaka, Japan
,
9   Department of Gastroenterology and Endoscopy, National Cancer Center-Hospital East, Kashiwa, Japan (Ringgold ID: RIN26351)
,
Yutaka Saito
10   Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan (Ringgold ID: RIN68380)
,
Yasuaki Nagami
11   Department of Gastroenterology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan
,
12   Department of Endoscopy, Fukushima Medical University Hospital, Fukushima, Japan (Ringgold ID: RIN215686)
,
Shinji Nagata
13   Department of Gastroenterology, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan (Ringgold ID: RIN13697)
,
Yuji Urabe
14   Department of Gastroenterology, Hiroshima University Hospital, Hiroshima, Japan (Ringgold ID: RIN68272)
,
Hiroyuki Ono
15   Division of Endoscopy, Shizuoka Cancer Center, Sunto-gun, Japan (Ringgold ID: RIN38471)
,
Hisashi Doyama
16   Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan (Ringgold ID: RIN37076)
,
Ko Nagino
17   Department of Gastroenterology, Yamagata Prefectural Central Hospital, Yamagata, Japan (Ringgold ID: RIN38106)
,
Toshihiko Tomita
18   Division of Gastroenterology and Hepatology, Hyogo Medical University, Nishinomiya, Japan (Ringgold ID: RIN12818)
,
Masashi Tamaoki
19   Department of Immuno-Oncology PDT, Kyoto University Graduate School of Medicine Faculty of Medicine, Kyoto, Japan (Ringgold ID: RIN38049)
,
Kazuya Ohno
20   Department of Gastroenterology, Shizuoka General Hospital, Shizuoka, Japan (Ringgold ID: RIN26389)
,
Masaaki Kobayashi
21   Department of Gastroenterology, Niigata Cancer Center Hospital, Niigata, Japan (Ringgold ID: RIN13721)
,
10   Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan (Ringgold ID: RIN68380)
,
Tomonori Yano
9   Department of Gastroenterology and Endoscopy, National Cancer Center-Hospital East, Kashiwa, Japan (Ringgold ID: RIN26351)
,
Manabu Muto
22   Department of Medical Oncology, Kyoto University Graduate School of Medicine Faculty of Medicine, Kyoto, Japan (Ringgold ID: RIN38049)
› Author Affiliations

Supported by: National Cancer Center Japan 2020-J-3,2023-J-03,26-A-4,29-A-3
Supported by: Japan Agency for Medical Research and Development JP15ck0106062 Clinical Trial: Registration number (trial ID): UMIN000014017, Trial registry: UMIN Japan (http://www.umin.ac.jp/english/), Type of Study: Prospective, Randomized, Multi-Center Study


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Abstract

Background

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.

Methods

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.

Results

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 P=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 P=0.99).

Conclusions

EBD combined with steroid injection is the standard treatment for refractory anastomotic stricture after esophagectomy.

Supplementary Material



Publication History

Received: 21 September 2024

Accepted after revision: 07 April 2025

Accepted Manuscript online:
08 April 2025

Article published online:
16 May 2025

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