Esophageal Fully Covered Metal Stents in Caustic Strictures Study

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Metal Stent (WallFlex™ Esophageal RX)

About this trial

This is an interventional treatment trial for Refractory Benign Esophageal Strictures Caused by Caustic Ingestion focused on measuring Refractory Benign Esophageal Strictures caused by Caustic Ingestion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Availability of medical history pertaining to dysphagia score prior to and during the preceding SECSER.
Availability of patient history pertaining to weight prior to and at completion of SECSER.
Benign esophageal stricture caused by caustic ingestion 12 or more weeks prior to enrollment.
Single esophageal stricture or multiple esophageal stricture over a length < 6 cm.
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.
Refractory stricture defined as recurrence of stricture with associated dysphagia within 6 months after completion of SECSER.
Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline.
Unable to pass a standard endoscope (approximately 9.8 mm diameter).
Age 18 years or older.
Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

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

Sites / Locations

Postgraduate Institute of Medical Education and Research
Asian Institute of Gastroenterology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metal Stent

Arm Description

The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS)is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion.

Outcomes

Primary Outcome Measures

Clinical Success

Clinical success consisting of stent tolerability and adequate ability to sustain nutrition to 6 months after stent removal. Stent tolerability defined as absence of pain-related stent removal. Adequate ability to sustain nutrition defined as absence of dysphagia-related reintervention.

Secondary Outcome Measures

Stent Placement Success

Number of participants with successful stent placement. Successful stent placement defined as the ability to deploy the stent in satisfactory position across the stricture

Stent Removal Success

Number of participants with successful stent removal. Successful stent removal defined as the ability to remove the stent endoscopically without serious stent removal related complications.

Change in Patient's Report on Pain Compared to Baseline

Change in Patient's report on pain compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, and Thereafter every 2 weeks until stent removal at Week 8. Pain is reported on the VAS Pain Score scale from 0 (0 being No Pain) to 10 (10 being Worst Pain Ever). Higher score means a worse outcome. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.

Change of Pain Medication Intake From Baseline

Change of pain medication intake from baseline at Day2, Week1, Week2, and thereafter every 2 weeks until stent removal

Change in Dysphagia Score Compared to Baseline

Change in dysphagia score compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, Week 8, and thereafter every 2 weeks until end of study at Week 32. Change value was calculated as dysphagia score measured during stent treatment minus dysphagia score at Baseline. Dysphagia is reported using Dysphagia Scoring System (see scoring system below) with higher score meaning a worse outcome. 0 = ability to eat a normal diet = ability to eat some solids = ability to eat some semisolids only = ability to swallow liquids only = complete dysphagia

Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER)

Change in Dysphagia score during stent treatment compared to dysphagia score during proceeding standardized esophageal caustic stricture endoscopic treatment regimen (SECSER). Change value was calculated as dysphagia score during stent treatment (Day 2, Week 1, Week 2, and thereafter every 2 weeks until end of study at Week 32 minus dysphagia score at SECSER. Dysphagia is reported using Dysphagia Scoring System (see scoring system below) with higher score meaning a worse outcome. 0. = ability to eat a normal diet = ability to eat some solids = ability to eat some semisolids only = ability to swallow liquids only = complete dysphagia

Change in Quality of Life (QOL) Compared to Baseline

Change in overall Quality of Life (QOL) health score compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, Week 8, and thereafter every 2 weeks until end of study at Week 32. QOL Overall Health Score is measured on a scale of 0 to 100, with 0 meaning the worst health you can imagine and 100 meaning the best health you can imagine. Higher score means a better outcome.

Occurrence of Adverse Events

Occurrence of Adverse Events Related to the Stent and/or the Stent Placement or Stent Removal Procedure and of All Serious Adverse Events Throughout the Duration of the Study

Time to Recurrence of Stricture

Time to Recurrence of Stricture, Defined as Inability of a Normal Diameter Gastroscope (9.8 mm) to Pass the Stricture

Number of Stent Migration With or Without Related Adverse Events

Number of stent migration with or without Related adverse events (AE). Stent migration is defined as any proximal or distal migration of stent.

Change in Patient Weight Compared to Baseline

Change in Patient Weight Compared to Baseline: Day 2, Week 1, Week 2, Week 4, Week 6, Week 8, and Thereafter Every 2 Weeks Until End of Study at Week 32. Positive value means increase in weight and negative value means decrease in weight.

Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER

Change in patient weight during stent treatment (day 2, week 1, week 2, week 4, week 6, week 8, and thereafter every 2 weeks until end of study at week 32) compared to preceding standardized esophageal caustic stricture endoscopic treatment regimen (SECSER). Positive value means increase in weight and negative value means decrease in weight.

Full Information

NCT ID

NCT01899300

First Posted

June 28, 2013

Last Updated

January 25, 2021

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01899300

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Benign Esophageal Strictures Caused by Caustic Ingestion

Keywords

Refractory Benign Esophageal Strictures caused by Caustic Ingestion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metal Stent

Arm Type

Experimental

Arm Description

The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS)is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion.

Intervention Type

Device

Intervention Name(s)

Metal Stent (WallFlex™ Esophageal RX)

Other Intervention Name(s)

WallFlex™ Esophageal RX Fully Covered Stent

Primary Outcome Measure Information:

Title

Clinical Success

Description

Clinical success consisting of stent tolerability and adequate ability to sustain nutrition to 6 months after stent removal. Stent tolerability defined as absence of pain-related stent removal. Adequate ability to sustain nutrition defined as absence of dysphagia-related reintervention.

Time Frame

From stent placement on day 0 to 6 months after stent removal

Secondary Outcome Measure Information:

Title

Stent Placement Success

Description

Number of participants with successful stent placement. Successful stent placement defined as the ability to deploy the stent in satisfactory position across the stricture

Time Frame

Stent placement on Day 0

Title

Stent Removal Success

Description

Number of participants with successful stent removal. Successful stent removal defined as the ability to remove the stent endoscopically without serious stent removal related complications.

Time Frame

Stent removal at Week 8 (±7 days)

Title

Change in Patient's Report on Pain Compared to Baseline

Description

Change in Patient's report on pain compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, and Thereafter every 2 weeks until stent removal at Week 8. Pain is reported on the VAS Pain Score scale from 0 (0 being No Pain) to 10 (10 being Worst Pain Ever). Higher score means a worse outcome. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.

Time Frame

From baseline to stent removal at Week 8 (±7 days)

Title

Change of Pain Medication Intake From Baseline

Description

Change of pain medication intake from baseline at Day2, Week1, Week2, and thereafter every 2 weeks until stent removal

Time Frame

From baseline to stent removal at Week 8 (±7 days)

Title

Change in Dysphagia Score Compared to Baseline

Description

Change in dysphagia score compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, Week 8, and thereafter every 2 weeks until end of study at Week 32. Change value was calculated as dysphagia score measured during stent treatment minus dysphagia score at Baseline. Dysphagia is reported using Dysphagia Scoring System (see scoring system below) with higher score meaning a worse outcome. 0 = ability to eat a normal diet = ability to eat some solids = ability to eat some semisolids only = ability to swallow liquids only = complete dysphagia

Time Frame

From stent placement on day 0 to end of study at Week 32.

Title

Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER)

Description

Change in Dysphagia score during stent treatment compared to dysphagia score during proceeding standardized esophageal caustic stricture endoscopic treatment regimen (SECSER). Change value was calculated as dysphagia score during stent treatment (Day 2, Week 1, Week 2, and thereafter every 2 weeks until end of study at Week 32 minus dysphagia score at SECSER. Dysphagia is reported using Dysphagia Scoring System (see scoring system below) with higher score meaning a worse outcome. 0. = ability to eat a normal diet = ability to eat some solids = ability to eat some semisolids only = ability to swallow liquids only = complete dysphagia

Time Frame

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

Title

Change in Quality of Life (QOL) Compared to Baseline

Description

Change in overall Quality of Life (QOL) health score compared to Baseline at Day 2, Week 1, Week 2, Week 4, Week 6, Week 8, and thereafter every 2 weeks until end of study at Week 32. QOL Overall Health Score is measured on a scale of 0 to 100, with 0 meaning the worst health you can imagine and 100 meaning the best health you can imagine. Higher score means a better outcome.

Time Frame

From stent placement on Day 0 to end of study at Week 32

Title

Occurrence of Adverse Events

Description

Occurrence of Adverse Events Related to the Stent and/or the Stent Placement or Stent Removal Procedure and of All Serious Adverse Events Throughout the Duration of the Study

Time Frame