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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Refractory Anastomotic Esophageal Strictures

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of procedures

Outcome Description:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Peter D. Siersema, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Study Principal Investigator

Authority:

Brazil: ANVISA Approval

Study ID:

CDM00049674

NCT ID:

NCT01699542

Start Date:

April 2013

Completion Date:

August 2015

Related Keywords:

  • Refractory Anastomotic Esophageal Strictures
  • Refractory Anastomotic esophageal strictures
  • Esophageal Diseases
  • Esophageal Stenosis
  • Constriction, Pathologic

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