Refractory Anastomotic Esophageal Strictures
Conditions
Keywords
Refractory Anastomotic esophageal strictures
Brief summary
The purpose of this of this study is to compare the safety and effectiveness of temporary indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of refractory anastomotic esophageal strictures
Interventions
DEVICEWallFlex Esophageal RX Fully Covered Stent
Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
DEVICEEsophageal Bougie Dilator Per Investigator preference
Commercially available Esophageal Bougie Dilator Per Investigator preference
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Esophageal anastomotic stricture post esophagectomy (esophagogastric strictures). * Esophagectomy performed at the same institution where patient enrollment and follow-up is planned. * Two dilations to at least 16 mm in diameter since esophagectomy. * 1st dilation no more than 6 months post esophagectomy and 2nd dilation within 6 months of 1st dilation to 16mm. * 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 (approx. 9.8 mm diameter). * Age 18 years or older. * Willing and able to comply with the study procedures and provide
Exclusion criteria
Stricture within 2 cm of the upper esophageal sphincter. * Dysphagia related to motility disorder. * Non-anastomotic esophageal strictures. * Esophagocolonic strictures. * Planned adjuvant radiation therapy post esophagectomy. * Prior esophageal stent placements post esophagectomy. * Active erosive esophagitis. * 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. * Stricture length \> 5 cm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Dilation Procedures | 12 months | Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Technical Stent Placement Success | 12 months | Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture. |
| Number of Participants With Technical Stent Removal Success | 12 months | Technical stent removal success is defined as the ability to remove the stent without complications. |
| Patient's Satisfaction With the Therapy | Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 | Patient's satisfaction with the therapy (scored by a visual analog scale) assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Patient Satisfaction with Therapy scale ranges from 0-10. The minimum on this scale is 0 (0 being completely unsatisfied with the therapy; a worse outcome) and the maximum on this scale is 10 (10 being completely satisfied with the therapy; a better outcome). |
| Patient's Report of Pain | Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 | Patient's report of pain (scored by a visual analog scale) assessed at Baseline, day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Pain Numerical Rating Scale ranges from 0-10. The minimum on this scale is 0 (0 being no pain; a better outcome) and the maximum on this scale is 10 (10 being worst pain ever; a worse outcome). |
| Number of Reinterventions Within 12 Months Following the Initial Study Treatment | 12 months | Number of reinterventions within 12 months following the initial study treatment. |
| Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure | 12 months | Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure. |
| Time to Recurrence of Dysphagia | 12 months | Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture. |
| Total Number of Stent Migrations | 12 months | Total number of stent migrations with or without symptoms. |
| Quality Of Life Overall Health Score | Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 | Quality of life scale measuring overall health score assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. The scale is numbered from 0 to 100. 0 is the worst health the participant can imagine. 100 is the best health the participant can imagine. A lower score indicates a worse outcome. A higher score indicates a better outcome. |
Countries
Brazil, Netherlands, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metal Stent The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell | 9 |
| Bougie Dilation Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Bougie Dilation | Total | Metal Stent |
|---|---|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 7.7 | 66.6 years STANDARD_DEVIATION 6.9 | 66.6 years STANDARD_DEVIATION 6.3 |
| Dysphagia Score Dysphagia Score = 2 | 9 Participants | 15 Participants | 6 Participants |
| Dysphagia Score Dysphagia Score > 2 | 0 Participants | 3 Participants | 3 Participants |
| Maximum Dilation | 15.9 mm STANDARD_DEVIATION 2 | 16.2 mm STANDARD_DEVIATION 1.5 | 16.4 mm STANDARD_DEVIATION 0.9 |
| Number of Pretreatment Dilations | 2.4 Pretreatment Dilations STANDARD_DEVIATION 1 | 2.2 Pretreatment Dilations STANDARD_DEVIATION 0.7 | 2.0 Pretreatment Dilations STANDARD_DEVIATION 0 |
| Quality of Life Overall Health Score | 80.0 units on a scale | 70.0 units on a scale | 65.0 units on a scale |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
| Type of Esophagectomy Transhiatal | 1 Participants | 4 Participants | 3 Participants |
| Type of Esophagectomy Transthoracic | 8 Participants | 14 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 5 / 9 | 0 / 9 |
| serious Total, serious adverse events | 1 / 9 | 0 / 9 |
Outcome results
Primary
Number of Dilation Procedures
Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metal Stent | Number of Dilation Procedures | 5.4 Dilation procedures | Standard Deviation 5.4 |
| Bougie Dilation | Number of Dilation Procedures | 2.4 Dilation procedures | Standard Deviation 2.5 |
p-value: 0.159Generalized Linear Model
Secondary
Number of Participants With Technical Stent Placement Success
Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture.
Time frame: 12 months
Population: Outcome measure only applicable to participants in the Metal Stent arm, as only participants in the Metal Stent arm received a stent. Participants in the Bougie Dilation arm did not receive a stent and therefore there is no data to collect regarding technical success of stent placement for the Bougie arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metal Stent | Number of Participants With Technical Stent Placement Success | 9 Participants |
| Bougie Dilation | Number of Participants With Technical Stent Placement Success | 0 Participants |
Secondary
Number of Participants With Technical Stent Removal Success
Technical stent removal success is defined as the ability to remove the stent without complications.
Time frame: 12 months
Population: Outcome measure only applicable to participants in the Metal Stent arm, as only participants in the Metal Stent arm received a stent and therefore underwent stent removal. Participants in the Bougie Dilation arm did not receive a stent and therefore there is no data to collect regarding technical success of stent removal for the Bougie arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metal Stent | Number of Participants With Technical Stent Removal Success | 9 Participants |
| Bougie Dilation | Number of Participants With Technical Stent Removal Success | 0 Participants |
Secondary
Number of Reinterventions Within 12 Months Following the Initial Study Treatment
Number of reinterventions within 12 months following the initial study treatment.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metal Stent | Number of Reinterventions Within 12 Months Following the Initial Study Treatment | 5.6 reinterventions | Standard Deviation 5.3 |
| Bougie Dilation | Number of Reinterventions Within 12 Months Following the Initial Study Treatment | 2.9 reinterventions | Standard Deviation 2.7 |
Secondary
Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure
Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metal Stent | Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure | Related Serious Adverse Events | 1 Participants |
| Metal Stent | Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure | Related Non-serious Adverse Events | 5 Participants |
| Bougie Dilation | Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure | Related Serious Adverse Events | 0 Participants |
| Bougie Dilation | Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure | Related Non-serious Adverse Events | 0 Participants |
Secondary
Patient's Report of Pain
Patient's report of pain (scored by a visual analog scale) assessed at Baseline, day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Pain Numerical Rating Scale ranges from 0-10. The minimum on this scale is 0 (0 being no pain; a better outcome) and the maximum on this scale is 10 (10 being worst pain ever; a worse outcome).
Time frame: Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Metal Stent | Patient's Report of Pain | Month 9 | 0.0 score on a scale |
| Metal Stent | Patient's Report of Pain | Month 2 | 0.0 score on a scale |
| Metal Stent | Patient's Report of Pain | Day 2 | 3.0 score on a scale |
| Metal Stent | Patient's Report of Pain | Week 2 | 1.0 score on a scale |
| Metal Stent | Patient's Report of Pain | Month 6 | 0.0 score on a scale |
| Metal Stent | Patient's Report of Pain | Baseline | 0.0 score on a scale |
| Metal Stent | Patient's Report of Pain | Month 12 | 0.0 score on a scale |
| Metal Stent | Patient's Report of Pain | Month 1 | 0.0 score on a scale |
| Metal Stent | Patient's Report of Pain | Month 3 | 0.0 score on a scale |
| Bougie Dilation | Patient's Report of Pain | Month 1 | 0.0 score on a scale |
| Bougie Dilation | Patient's Report of Pain | Day 2 | 0.0 score on a scale |
| Bougie Dilation | Patient's Report of Pain | Baseline | 0.0 score on a scale |
| Bougie Dilation | Patient's Report of Pain | Week 2 | 0.0 score on a scale |
| Bougie Dilation | Patient's Report of Pain | Month 6 | 0.0 score on a scale |
| Bougie Dilation | Patient's Report of Pain | Month 2 | 0.0 score on a scale |
| Bougie Dilation | Patient's Report of Pain | Month 3 | 0.0 score on a scale |
| Bougie Dilation | Patient's Report of Pain | Month 9 | 0.0 score on a scale |
| Bougie Dilation | Patient's Report of Pain | Month 12 | 0.0 score on a scale |
Secondary
Patient's Satisfaction With the Therapy
Patient's satisfaction with the therapy (scored by a visual analog scale) assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Patient Satisfaction with Therapy scale ranges from 0-10. The minimum on this scale is 0 (0 being completely unsatisfied with the therapy; a worse outcome) and the maximum on this scale is 10 (10 being completely satisfied with the therapy; a better outcome).
Time frame: Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Metal Stent | Patient's Satisfaction With the Therapy | Day 2 | 8.0 score on a scale |
| Metal Stent | Patient's Satisfaction With the Therapy | Week 2 | 8.0 score on a scale |
| Metal Stent | Patient's Satisfaction With the Therapy | Month 1 | 9.0 score on a scale |
| Metal Stent | Patient's Satisfaction With the Therapy | Month 2 | 9.0 score on a scale |
| Metal Stent | Patient's Satisfaction With the Therapy | Month 3 | 8.0 score on a scale |
| Metal Stent | Patient's Satisfaction With the Therapy | Month 6 | 8.0 score on a scale |
| Metal Stent | Patient's Satisfaction With the Therapy | Month 9 | 9.5 score on a scale |
| Metal Stent | Patient's Satisfaction With the Therapy | Month 12 | 9.0 score on a scale |
| Bougie Dilation | Patient's Satisfaction With the Therapy | Month 12 | 10.0 score on a scale |
| Bougie Dilation | Patient's Satisfaction With the Therapy | Day 2 | 10.0 score on a scale |
| Bougie Dilation | Patient's Satisfaction With the Therapy | Month 3 | 8.0 score on a scale |
| Bougie Dilation | Patient's Satisfaction With the Therapy | Week 2 | 9.5 score on a scale |
| Bougie Dilation | Patient's Satisfaction With the Therapy | Month 9 | 9.0 score on a scale |
| Bougie Dilation | Patient's Satisfaction With the Therapy | Month 1 | 10.0 score on a scale |
| Bougie Dilation | Patient's Satisfaction With the Therapy | Month 6 | 9.0 score on a scale |
| Bougie Dilation | Patient's Satisfaction With the Therapy | Month 2 | 8.0 score on a scale |
Secondary
Quality Of Life Overall Health Score
Quality of life scale measuring overall health score assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. The scale is numbered from 0 to 100. 0 is the worst health the participant can imagine. 100 is the best health the participant can imagine. A lower score indicates a worse outcome. A higher score indicates a better outcome.
Time frame: Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Metal Stent | Quality Of Life Overall Health Score | Day 2 | 70.0 score on a scale |
| Metal Stent | Quality Of Life Overall Health Score | Week 2 | 70.0 score on a scale |
| Metal Stent | Quality Of Life Overall Health Score | Month 1 | 80.0 score on a scale |
| Metal Stent | Quality Of Life Overall Health Score | Month 2 | 80.0 score on a scale |
| Metal Stent | Quality Of Life Overall Health Score | Month 3 | 75.0 score on a scale |
| Metal Stent | Quality Of Life Overall Health Score | Month 6 | 67.5 score on a scale |
| Metal Stent | Quality Of Life Overall Health Score | Month 9 | 70.0 score on a scale |
| Metal Stent | Quality Of Life Overall Health Score | Month 12 | 75.0 score on a scale |
| Bougie Dilation | Quality Of Life Overall Health Score | Month 12 | 70.0 score on a scale |
| Bougie Dilation | Quality Of Life Overall Health Score | Day 2 | 75.0 score on a scale |
| Bougie Dilation | Quality Of Life Overall Health Score | Month 3 | 85.0 score on a scale |
| Bougie Dilation | Quality Of Life Overall Health Score | Week 2 | 80.0 score on a scale |
| Bougie Dilation | Quality Of Life Overall Health Score | Month 9 | 80.0 score on a scale |
| Bougie Dilation | Quality Of Life Overall Health Score | Month 1 | 80.0 score on a scale |
| Bougie Dilation | Quality Of Life Overall Health Score | Month 6 | 85.0 score on a scale |
| Bougie Dilation | Quality Of Life Overall Health Score | Month 2 | 77.5 score on a scale |
Secondary
Time to Recurrence of Dysphagia
Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture.
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Metal Stent | Time to Recurrence of Dysphagia | 36 Days |
| Bougie Dilation | Time to Recurrence of Dysphagia | 33 Days |
Secondary
Total Number of Stent Migrations
Total number of stent migrations with or without symptoms.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metal Stent | Total Number of Stent Migrations | 2 stent migrations |
| Bougie Dilation | Total Number of Stent Migrations | 0 stent migrations |