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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

Typical endoscopic view 1 month after endoscopic submucosal dissection. Severe stenosis of the esophagus did not develop. The right picture (a) is a magnification of the left picture (b).
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Fig5: Typical endoscopic view 1 month after endoscopic submucosal dissection. Severe stenosis of the esophagus did not develop. The right picture (a) is a magnification of the left picture (b).

Mentions: Esophagogastroduodenoscopy (EGD) was performed to assess for stenosis, bleeding or perforation at the injected sites 6 days after treatment (Figure 2). Barium contrast esophagography was performed in patients who complained of dysphagia, or 4 weeks after the last EGD if patients were asymptomatic, to quantitatively assess stenosis (Figure 3). Esophageal stenosis was defined as an esophageal diameter <11 mm, rather than the inability to pass the gastroscope (which had a diameter of 9.8–11.0 mm) or inability to achieve or maintain a diameter of 14 mm despite dilatation every 2–4 weeks [5,16]. The luminal diameter was estimated by measurement of the minimum diameter of the stricture on esophagography (for examples, see Figures 3 and 4). Dilatation therapy was performed every 1–4 weeks as previously described [3]. Briefly, dilatation was performed in the outpatient department under fluoroscopic guidance using a Maloney (Medovations, Milwaukee, WI) or Savary (Wilson Cook Medical, Winston-Salem, NC) wire-guided dilator [17]. Dilatation therapy was considered successful when patients did not report any symptoms of dysphagia without having needed dilatation in the previous 4 weeks (Figure 5).Figure 2


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)

Typical endoscopic view 1 month after endoscopic submucosal dissection. Severe stenosis of the esophagus did not develop. The right picture (a) is a magnification of the left picture (b).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig5: Typical endoscopic view 1 month after endoscopic submucosal dissection. Severe stenosis of the esophagus did not develop. The right picture (a) is a magnification of the left picture (b).
Mentions: Esophagogastroduodenoscopy (EGD) was performed to assess for stenosis, bleeding or perforation at the injected sites 6 days after treatment (Figure 2). Barium contrast esophagography was performed in patients who complained of dysphagia, or 4 weeks after the last EGD if patients were asymptomatic, to quantitatively assess stenosis (Figure 3). Esophageal stenosis was defined as an esophageal diameter <11 mm, rather than the inability to pass the gastroscope (which had a diameter of 9.8–11.0 mm) or inability to achieve or maintain a diameter of 14 mm despite dilatation every 2–4 weeks [5,16]. The luminal diameter was estimated by measurement of the minimum diameter of the stricture on esophagography (for examples, see Figures 3 and 4). Dilatation therapy was performed every 1–4 weeks as previously described [3]. Briefly, dilatation was performed in the outpatient department under fluoroscopic guidance using a Maloney (Medovations, Milwaukee, WI) or Savary (Wilson Cook Medical, Winston-Salem, NC) wire-guided dilator [17]. Dilatation therapy was considered successful when patients did not report any symptoms of dysphagia without having needed dilatation in the previous 4 weeks (Figure 5).Figure 2

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