Clinical trial NCT01899300: Esophageal Fully Covered Metal Stents in Caustic Strictures Study
Official title: A Multi-Center, Prospective, Evaluation of the Use of a Fully Covered Metal Stent (FCMS) for the Treatment of Refractory Benign Esophageal Strictures Caused by Caustic Ingestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Benign Esophageal Strictures Caused by Caustic Ingestion
Keywords: Refractory Benign Esophageal Strictures caused by Caustic Ingestion
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-07-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish clinical proof of concept of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal strictures caused by caustic ingestion.

Detailed description: The purpose of this study is to establish clinical proof of concept of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal strictures caused by caustic ingestion. Also to collect data in support of a hypothesis required to prospectively document the safety and effectiveness of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) compared to repeated Bougie Dilation for the treatment of refractory benign esophageal strictures caused by caustic ingestion.

Eligibility criteria: Inclusion Criteria:

1. Availability of medical history pertaining to dysphagia score prior to and during the preceding SECSER.
2. Availability of patient history pertaining to weight prior to and at completion of SECSER.
3. Benign esophageal stricture caused by caustic ingestion 12 or more weeks prior to enrollment.
4. Single esophageal stricture or multiple esophageal stricture over a length \< 6 cm.
5. Having completed the SECSER consisting of 3 dilations intended to reach 15 mm each, separated by 2 weeks, followed by 3 dilations intended to reach 15 mm each with steroid injections, separated by 2 weeks. The dilations may be performed using Bougie or balloon dilation at the discretion of the investigator.
6. Refractory stricture defined as recurrence of stricture with associated dysphagia within 6 months after completion of SECSER.
7. Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline.
8. Unable to pass a standard endoscope (approximately 9.8 mm diameter).
9. Age 18 years or older.
10. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Stricture within 2 cm of the upper esophageal sphincter.
2. Concomitant Esophageal ulcerations.
3. Prior esophageal stent placements.
4. Concurrent gastric and/or duodenal obstruction.
5. Patients with prior full or partial gastrectomy.
6. Sensitivity to any components of the stent or delivery system.
7. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
8. Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.

Primary outcomes:
measure: Clinical Success
timeFrame: From stent placement on day 0 to 6 months after stent removal
Secondary outcomes:
measure: Stent Placement Success
timeFrame: Stent placement on Day 0
measure: Stent Removal Success
timeFrame: Stent removal at Week 8 (±7 days)
measure: Change in Patient's Report on Pain Compared to Baseline
timeFrame: From baseline to stent removal at Week 8 (±7 days)
measure: Change of Pain Medication Intake From Baseline
timeFrame: From baseline to stent removal at Week 8 (±7 days)
measure: Change in Dysphagia Score Compared to Baseline
timeFrame: From stent placement on day 0 to end of study at Week 32.
measure: Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER)
timeFrame: Dysphagia score at SECSER was measured prior to baseline. Dysphagia score during stent treatment was measured from stent placement on day 0 to end of study at Week 32
measure: Change in Quality of Life (QOL) Compared to Baseline
timeFrame: From stent placement on Day 0 to end of study at Week 32
measure: Occurrence of Adverse Events
timeFrame: From stent placement on Day 0 to end of study at Week 32.
measure: Time to Recurrence of Stricture
timeFrame: From stent placement on Day 0 to end of study at Week 32.
measure: Number of Stent Migration With or Without Related Adverse Events
timeFrame: From stent placement on Day 0 to end of study at Week 32.
measure: Change in Patient Weight Compared to Baseline
timeFrame: From stent placement on Day 0 to end of study at Week 32.
measure: Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER
timeFrame: From stent placement on Day 0 to end of study at Week 32.
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
Study officials:
References: