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A randomized controlled trial of endoscopic steroid injection for prophylaxis of esophageal stenoses after extensive endoscopic submucosal dissection.

Takahashi H, Arimura Y, Okahara S, Kodaira J, Hokari K, Tsukagoshi H, Shinomura Y, Hosokawa M - BMC Gastroenterol (2015)

Bottom Line: The perforation rate was similar in both groups.The minimum diameter of stenotic lumens was significantly greater in the treatment group than controls (11.0 mm versus 7.1 mm, respectively; P = 0.01).The perforation rate was not significantly different between the groups (1.0% versus 0.5% in the treatment and control group, respectively).

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology, Keiyukai Daini Hospital, Hondori-13, Shiroishi-ku, Sapporo, 003-0027, Japan. takahashi@keiyukaisapporo.or.jp.

ABSTRACT

Background: Esophageal stenosis following endoscopic submucosal dissection (ESD) is a serious adverse event that makes subsequent management more difficult.

Methods: This parallel, randomized, controlled, open-label study was designed to examine whether local steroid injection is an effective prophylactic treatment for esophageal stenoses following extensive ESD. This single center trial was conducted at the Keiyukai Hospital, a tertiary care center for gastrointestinal disease in Japan [University Hospital Medical Network Clinical Trial Registry (UMIN-CTR) on 15 September 2011 (UMIN000006327)]. Thirty-two patients with mucosal defects involving ≥75% of the esophageal circumference were randomized to receive a single dose of triamcinolone acetonide injections (n = 16) or be treated conventionally (n = 16). The primary outcome was the frequency of stricture requiring endoscopic dilatation; the surrogate primary endpoint was the number of dilatation sessions needed. Secondary outcomes included adverse event rates, the minimum diameter of the stenotic area and the duration of the course of dilatation treatments.

Results: The frequency of stricture was not significantly different between the groups because of insufficient statistical power, but the number of dilatation sessions required was significantly less in the steroid group (6.1 sessions [95% confidence interval, CI 2.8-9.4] versus 12.5 [95% CI 7.1-17.9] sessions in the control group; P = 0.04). The perforation rate was similar in both groups. The minimum diameter of stenotic lumens was significantly greater in the treatment group than controls (11.0 mm versus 7.1 mm, respectively; P = 0.01). The perforation rate was not significantly different between the groups (1.0% versus 0.5% in the treatment and control group, respectively). Steroid injection was effective in cases of mucosal defects encompassing the entire esophageal circumference.

Conclusions: Prophylactic endoscopic steroid injection appears to be a safe means of relieving the severity of esophageal stenoses following extensive ESD.

No MeSH data available.


Related in: MedlinePlus

Study flow chart. Patients with an expected circumferential mucosal defect involving ≥75% of the circumference of the esophagus after ESD were eligible. Patients were excluded if they had received additional adjuvant treatments, such as surgery or chemoradiation therapy, or if they were not adequately followed-up.
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Fig6: Study flow chart. Patients with an expected circumferential mucosal defect involving ≥75% of the circumference of the esophagus after ESD were eligible. Patients were excluded if they had received additional adjuvant treatments, such as surgery or chemoradiation therapy, or if they were not adequately followed-up.

Mentions: Recruitment began in February 2010 and the last follow-up was in October 2011. The trial ended because data were considered complete. During the study period, 209 patients with 256 lesions underwent ESD in our hospital, 42 of whom (20.1%) were enrolled in the study because they were expected to have mucosal defects extending over three-quarters of the esophageal circumference due to the ESD. Since one of these 42 patients declined to participate, in total 41 were enrolled and randomized. 21 were allocated to the injection (treatment) group whereas 20 were allocated to the non-injection (control) group. However, after ESD, nine patients were excluded from the study: one whose follow-up was inadequate and eight who received additional therapy. Of the latter eight patients, seven had submucosal invasion that exceeded 200 μm and one had lymphatic invasion despite a depth of invasion of only 180 μm. Ultimately, 16 patients were allocated to each group (Figure 6).Figure 6


A randomized controlled trial of endoscopic steroid injection for prophylaxis of esophageal stenoses after extensive endoscopic submucosal dissection.

Takahashi H, Arimura Y, Okahara S, Kodaira J, Hokari K, Tsukagoshi H, Shinomura Y, Hosokawa M - BMC Gastroenterol (2015)

Study flow chart. Patients with an expected circumferential mucosal defect involving ≥75% of the circumference of the esophagus after ESD were eligible. Patients were excluded if they had received additional adjuvant treatments, such as surgery or chemoradiation therapy, or if they were not adequately followed-up.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4308850&req=5

Fig6: Study flow chart. Patients with an expected circumferential mucosal defect involving ≥75% of the circumference of the esophagus after ESD were eligible. Patients were excluded if they had received additional adjuvant treatments, such as surgery or chemoradiation therapy, or if they were not adequately followed-up.
Mentions: Recruitment began in February 2010 and the last follow-up was in October 2011. The trial ended because data were considered complete. During the study period, 209 patients with 256 lesions underwent ESD in our hospital, 42 of whom (20.1%) were enrolled in the study because they were expected to have mucosal defects extending over three-quarters of the esophageal circumference due to the ESD. Since one of these 42 patients declined to participate, in total 41 were enrolled and randomized. 21 were allocated to the injection (treatment) group whereas 20 were allocated to the non-injection (control) group. However, after ESD, nine patients were excluded from the study: one whose follow-up was inadequate and eight who received additional therapy. Of the latter eight patients, seven had submucosal invasion that exceeded 200 μm and one had lymphatic invasion despite a depth of invasion of only 180 μm. Ultimately, 16 patients were allocated to each group (Figure 6).Figure 6

Bottom Line: The perforation rate was similar in both groups.The minimum diameter of stenotic lumens was significantly greater in the treatment group than controls (11.0 mm versus 7.1 mm, respectively; P = 0.01).The perforation rate was not significantly different between the groups (1.0% versus 0.5% in the treatment and control group, respectively).

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology, Keiyukai Daini Hospital, Hondori-13, Shiroishi-ku, Sapporo, 003-0027, Japan. takahashi@keiyukaisapporo.or.jp.

ABSTRACT

Background: Esophageal stenosis following endoscopic submucosal dissection (ESD) is a serious adverse event that makes subsequent management more difficult.

Methods: This parallel, randomized, controlled, open-label study was designed to examine whether local steroid injection is an effective prophylactic treatment for esophageal stenoses following extensive ESD. This single center trial was conducted at the Keiyukai Hospital, a tertiary care center for gastrointestinal disease in Japan [University Hospital Medical Network Clinical Trial Registry (UMIN-CTR) on 15 September 2011 (UMIN000006327)]. Thirty-two patients with mucosal defects involving ≥75% of the esophageal circumference were randomized to receive a single dose of triamcinolone acetonide injections (n = 16) or be treated conventionally (n = 16). The primary outcome was the frequency of stricture requiring endoscopic dilatation; the surrogate primary endpoint was the number of dilatation sessions needed. Secondary outcomes included adverse event rates, the minimum diameter of the stenotic area and the duration of the course of dilatation treatments.

Results: The frequency of stricture was not significantly different between the groups because of insufficient statistical power, but the number of dilatation sessions required was significantly less in the steroid group (6.1 sessions [95% confidence interval, CI 2.8-9.4] versus 12.5 [95% CI 7.1-17.9] sessions in the control group; P = 0.04). The perforation rate was similar in both groups. The minimum diameter of stenotic lumens was significantly greater in the treatment group than controls (11.0 mm versus 7.1 mm, respectively; P = 0.01). The perforation rate was not significantly different between the groups (1.0% versus 0.5% in the treatment and control group, respectively). Steroid injection was effective in cases of mucosal defects encompassing the entire esophageal circumference.

Conclusions: Prophylactic endoscopic steroid injection appears to be a safe means of relieving the severity of esophageal stenoses following extensive ESD.

No MeSH data available.


Related in: MedlinePlus