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Completed

NCT Number: NCT01699542

WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture

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

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Key information

Conditions

Refractory Anastomotic Esophageal Strictures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto do Cancer do Estado de Sao Paulo, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WallFlex Esophageal RX Fully Covered Stent

Device

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

Esophageal Bougie Dilator Per Investigator preference

Device

Commercially available Esophageal Bougie Dilator Per Investigator preference

Primary outcomes

  1. Number of Dilation Procedures

    Time frame: 12 months

    Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.

Secondary outcomes

  1. Number of Participants With Technical Stent Placement Success

    Time frame: 12 months

    Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture.

  2. Number of Participants With Technical Stent Removal Success

    Time frame: 12 months

    Technical stent removal success is defined as the ability to remove the stent without complications.

  3. Patient's Satisfaction With the Therapy

    Time frame: 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).

  4. Patient's Report of Pain

    Time frame: 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).

  5. Quality Of Life Overall Health Score

    Time frame: 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.

  6. Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure

    Time frame: 12 months

    Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure.

  7. Time to Recurrence of Dysphagia

    Time frame: 12 months

    Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture.

  8. Total Number of Stent Migrations

    Time frame: 12 months

    Total number of stent migrations with or without symptoms.

  9. Number of Reinterventions Within 12 Months Following the Initial Study Treatment

    Time frame: 12 months

    Number of reinterventions within 12 months following the initial study treatment.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

A Multi-Center, Prospective, Randomized (RCT) Study Comparing WallFlex® Esophageal Fully Covered (FC) Metal Stent to Bougie Dilation for the Treatment of Refractory Anastomotic Esophageal Strictures

Acronym: E7025

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 3, 2012
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.