Trial Outcomes & Findings for Esophageal Fully Covered Metal Stents in Caustic Strictures Study (NCT NCT01899300)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

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

Results posted on

2021-02-12

Participant Flow

Twenty (20) patients with refractory benign esophageal strictures caused by caustic ingestion were planned to be enrolled at 2-4 centers in India. * Group 1: Patients 1-10, stent indwell for 8 weeks +/- 7 days. * Group 2: Patients 11-20, stent indwell for 12 weeks +/- 7 days.

Participant milestones

Participant milestones
Measure	Metal Stent 8 Week Indwell Patients 1 to 10 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 8 weeks +/- 7 days	Metal Stent 12 Week Indwell Patients 11 to 20 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 12 weeks +/- 7 days
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Esophageal Fully Covered Metal Stents in Caustic Strictures Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metal Stent 8 Week Indwell n=1 Participants Patients 1 to 10 were to receive the WallFlex Esophageal Fully Covered Self-Expanding Metal Stent with stent indwell for 8 weeks +/- 7 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54 Years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment India	1 participants n=5 Participants

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Metal Stent 8 Week Indwell n=1 Participants The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion. Metal Stent (WallFlex™ Esophageal RX)
Clinical Success	1 Participants

SECONDARY outcome

Timeframe: Stent placement on Day 0

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

Outcome measures

Outcome measures
Measure	Metal Stent 8 Week Indwell n=1 Participants The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion. Metal Stent (WallFlex™ Esophageal RX)
Stent Placement Success	1 Participants

SECONDARY outcome

Timeframe: Stent removal at Week 8 (±7 days)

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.

Outcome measures

Outcome measures
Measure	Metal Stent 8 Week Indwell n=1 Participants The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion. Metal Stent (WallFlex™ Esophageal RX)
Stent Removal Success	1 Participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Metal Stent 8 Week Indwell n=1 Participants The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion. Metal Stent (WallFlex™ Esophageal RX)
Change in Patient's Report on Pain Compared to Baseline Day 2 vs Baseline	0 score on a scale
Change in Patient's Report on Pain Compared to Baseline Week 1 vs Baseline	1 score on a scale
Change in Patient's Report on Pain Compared to Baseline Week 2 vs Baseline	0 score on a scale
Change in Patient's Report on Pain Compared to Baseline Week 4 vs Baseline	1 score on a scale
Change in Patient's Report on Pain Compared to Baseline Week 6 vs Baseline	1 score on a scale
Change in Patient's Report on Pain Compared to Baseline Week 8 vs Baseline	0 score on a scale

SECONDARY outcome

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

Population: Pain medication intake data not collected

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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 1. = ability to eat some solids 2. = ability to eat some semisolids only 3. = ability to swallow liquids only 4. = complete dysphagia

Outcome measures

Outcome measures
Measure	Metal Stent 8 Week Indwell n=1 Participants The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion. Metal Stent (WallFlex™ Esophageal RX)
Change in Dysphagia Score Compared to Baseline Week 30 vs Baseline	-1 Score on a scale
Change in Dysphagia Score Compared to Baseline Day2 vs Baseline	0 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 1 vs Baseline	0 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 2 vs Baseline	0 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 4 vs Baseline	0 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 6 vs Baseline	0 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 8 vs Baseline	0 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 10 vs Baseline	0 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 12 vs Baseline	0 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 14 vs Baseline	-1 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 16 vs Baseline	-1 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 18 vs Baseline	-1 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 20 vs Baseline	-1 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 22 vs Baseline	-1 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 24 vs Baseline	-1 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 26 vs Baseline	-1 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 28 vs Baseline	-1 Score on a scale
Change in Dysphagia Score Compared to Baseline Week 32 vs Baseline	-1 Score on a scale

SECONDARY outcome

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

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 1. = ability to eat some solids 2. = ability to eat some semisolids only 3. = ability to swallow liquids only 4. = complete dysphagia

Outcome measures

Outcome measures
Measure	Metal Stent 8 Week Indwell n=1 Participants The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion. Metal Stent (WallFlex™ Esophageal RX)
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 24 vs SECSR	-2 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Day2 vs SECSR	-1 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 1 vs SECSR	-1 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 2 vs SECSR	-1 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 4 vs SECSR	-1 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 6 vs SECSR	-1 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 8 vs SECSR	-1 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 10 vs SECSR	-1 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 12 vs SECSR	-1 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 14 vs SECSR	-2 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 16 vs SECSR	-2 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 18 vs SECSR	-2 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 20 vs SECSR	-2 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 22 vs SECSR	-2 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 26 vs SECSR	-2 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 28 vs SECSR	-2 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 30 vs SECSR	-2 Score on a scale
Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER) Week 32 vs SECSR	-2 Score on a scale

SECONDARY outcome

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

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.