Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

Esophageal Anastomotic Stricture Clinical Trial

Official title:

Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02703376
• Other study ID #: NagasakiU2
• Status: Recruiting
• Phase: Phase 1
• First received: January 18, 2016
• Last updated: March 3, 2016
• Start date: January 2016
• Est. completion date: October 2019

Study information

• Verified date: March 2016
• Source: Nagasaki University
• Contact: Kobayashi Shinichiro, M.D.
• Phone: +81958197316
• Email: skobayashi1980[@]gmail.com
• Is FDA regulated: No
• Health authority: Japan: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.

Description:

Esophageal strictures are common complications after surgery and aggressive endoscopic submucosal dissection (ESD) for early-stage esophageal cancer and adenocarcinoma. However, patients, who develop esophageal strictures after extensive operations, usually develop refractory strictures. Although there are several treatments for refractory strictures, their utility is limited.

Yamaguchi and colleagues have developed new treatments using oral prednisolone. They have shown the safety and potential efficacy to prevent esophageal strictures after ESD. However, the efficacy and safety of oral prednisolone is not evaluated to esophageal stricture after esophageal surgery.

This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: October 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• The patients who develop the severe esophageal strictures from 28 days after esophageal surgery

Exclusion Criteria:

• Pulmonary and cardiac disorders

• Liver and renal dysfunctions

• Allergic

• Pregnancy

• infectious disease

• Unsuitable condition

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Constriction, Pathologic
• Esophageal Anastomotic Stricture
• Esophageal Stenosis

Intervention

Drug:
• Oral Prednisone
Intakes of Oral Prednisone for 12 weeks after balloon dilations

Locations

Country	Name	City	State
Japan	Nagasaki University	Nagasaki

Sponsors (1)

Lead Sponsor	Collaborator
Nagasaki University

Country where clinical trial is conducted

Japan, 

References & Publications (2)

Kobayashi S, Kanai N, Ohki T, Takagi R, Yamaguchi N, Isomoto H, Kasai Y, Hosoi T, Nakao K, Eguchi S, Yamamoto M, Yamato M, Okano T. Prevention of esophageal strictures after endoscopic submucosal dissection. World J Gastroenterol. 2014 Nov 7;20(41):15098-109. doi: 10.3748/wjg.v20.i41.15098. Review. — View Citation

Yamaguchi N, Isomoto H, Nakayama T, Hayashi T, Nishiyama H, Ohnita K, Takeshima F, Shikuwa S, Kohno S, Nakao K. Usefulness of oral prednisolone in the treatment of esophageal stricture after endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma. Gastrointest Endosc. 2011 Jun;73(6):1115-21. doi: 10.1016/j.gie.2011.02.005. Epub 2011 Apr 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification		for 12 weeks after the intervention	Yes
Primary	Incidence of Adverse Events of Grade 3 and Grade 4 of CTCAE v4.0	physical conditions, clinical laboratory abnormalities, and ECG abnormalities	for 12 weeks after the intervention	Yes
Primary	Incidence of treatment discontinuations, modifications, and interruptions due to adverse events		for 12 weeks after the intervention	Yes
Secondary	Rate of re-strictures at 85 postoperative days		for 12 weeks after the intervention	No
Secondary	Number of participants with endoscopic classification of strictures before intervention		before the intervention	No
Secondary	Dysphagia score		for 12 weeks after the intervention	No
Secondary	Session of the dilatation		for 12 weeks after the intervention	No