Clinical trial NCT02703376: Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery
Official title: Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Esophageal Anastomotic Stricture
Lead sponsor: Nagasaki University
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification
timeFrame: for 12 weeks after the intervention
measure: Incidence of Adverse Events of Grade 3 and Grade 4 of CTCAE v4.0
timeFrame: for 12 weeks after the intervention
measure: Incidence of treatment discontinuations, modifications, and interruptions due to adverse events
timeFrame: for 12 weeks after the intervention
Secondary outcomes:
measure: Rate of re-strictures at 85 postoperative days
timeFrame: for 12 weeks after the intervention
measure: Number of participants with endoscopic classification of strictures before intervention
timeFrame: before the intervention
measure: Dysphagia score
timeFrame: for 12 weeks after the intervention
measure: Session of the dilatation
timeFrame: for 12 weeks after the intervention
Other outcomes:
Locations:
city: Nagasaki
country: Japan
facility: Nagasaki University
Study officials:
affiliation: Department of Surgery Nagasaki University Graduate School of Biomedical Sciences
name: Kobayashi Shinichiro
role: STUDY_DIRECTOR
References:
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.
citation: 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.