To demonstrate that management of dysphagia for the treatment of refractory anastomotic esophageal strictures is more effective with Fully Covered metal stent than with Bougie Dilation.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of dilation procedures for the management of dysphagia within 12 months
following initial study treatment.
Secondary outcome
1. Occurrence and severity of adverse events related to the stent/bougie
dilator and/or the procedures.
2. Ability to deploy the stent in satisfactory position across the stricture
(technical success at placement).
3. Ability to remove the stent without complications (technical success at
stent removal).
4. Time to recurrence of dysphagia.
5. Improvement and detailed analysis of dysphagia at each follow up visits.
6. Incidence of migration with or without symptoms.
7. Number of reinterventions within 12 months following the initial study
treatment.
8. Number of days patient is symptom free during the stent indwell period.
9. Patient's satisfaction with the therapy (scored by a visual analogue scale):
1st month-daily, 2-6 months-weekly.
10. Patient*s report on pain (scored by a visual analog scale): 1st
month-daily, 2-6 months-weekly.
11. Quality Of Life (QOL): Improvement in EQ-5D-5L at Baseline, week 2, Months
1, 3, 6, 9 and 12.
12. Patient diary to assess dysphagia scores: 1st month-daily, 2-6
months-weekly.
13. Economic endpoints:
o Length of procedure (stent placement, stent removal,
bougie dilations)
o Number of outpatient procedures
o Number and length of hospitalizations
o Number of devices used
Background summary
Esophageal cancer is a highly lethal malignancy with only modest improvement in
survival rates over the last three decades. Surgery with or without adjuvant
chemotherapy offers the only option for a potential cure in patients with early
stage disease. The surgical therapies for esophageal cancer are invasive
procedures with substantial morbidity and mortality rates. Common complications
following esophagectomy include anastomotic leaks and strictures, as well as
fistula formation.
The mainstay of management of benign esophageal strictures is esophageal
dilation. Several techniques for dilation exist. The use of a specific dilation
technique is dictated by the character of the stricture. Adjuncts to the
management of difficult benign esophageal strictures include steroid injection,
use of cautery, and more recently, the use of self-expanding removable metal
stents. As a result of these improvements on endoscopic techniques, the
indications for surgical intervention in difficult refractory benign esophageal
strictures are changing and likely will decrease in the future.
The most common causes of benign strictures of the esophagus are anastomotic
strictures, which can develop following resection of the distal esophagus and
proximal stomach for treatment of esophageal cancer1.
Fully-covered self-expanding metal stents (FCSEMS) have recently become
available for use in the esophagus. The fully-covered nature of these metal
endoprostheses appears to allow for long-term removability, thus permitting
their use in both malignant and benign disease. Like traditional uncovered
metal stents, FCSEMS offer the advantage of a thin (6*8 mm), flexible delivery
catheter that can be easily operated and deployed in the proximal esophagus.
Complications associated with the use of self-expanding metal stents include
stent migration, bleeding after stent removal, hyperplastic tissue growth and
pain. The use of FCSEMS for the management of postoperative complications
following esophagectomy has not been well studied.
This study will compare the safety and effectiveness of temporary indwell of
the WallFlex® Esophageal Fully Covered Metal Stent to Bougie Dilations for the
treatment of refractory anastomotic esophageal strictures.
Study objective
To demonstrate that management of dysphagia for the treatment of refractory
anastomotic esophageal strictures is more effective with Fully Covered metal
stent than with Bougie Dilation.
Study design
The study is designed as a pre-market, multi-center, prospective, randomized
study. Four to six sites will participate, and enrollment of 44 patients is
planned in a 1:1 randomization scheme. The proposed duration of the study is
approximately 2.5 years allowing 18 months for enrollment/treatment plus 12
months (from initial study treatment) to complete follow-up.
Intervention
Patients who are consented and meet in- and exclusion criteria will undergo a
treatment according to the stent arm (group A) or the bougie dilation arm
(group B).
Group A * Stent Arm: Subjects in the Stent arm will be treated with a single
metal stent, which will be removed 8 weeks +/- 1 week post-placement. After
stent removal, if dysphagia recurs, bougie dilation will be repeated as needed
until 12 months after enrollment.
Group B * Bougie Dilation Arm: Subjects in the Bougie Dilation arm will receive
dilations up to 16 mm at time 0. This may require 1 to 4 dilation sessions.
Date of first dilation session will be defined as time 0 and date of last
dilation session will be defined as completion of the initial study treatment.
Follow up does not start until the last day of the completion date. If there is
recurrence of dysphagia after the initial study bougie dilation, dilation will
be repeated as needed until 12 months after enrollment.
Study burden and risks
The potential adverse effects associated with esophageal stent placement may
include:
* Bleeding
* Perforation
* Pain
* Aspiration
* Stent migration
* Tissue overgrowth around stent ends
* Foreign body sensation
* Food bolus impaction
* Reflux
* Esophagitis
* Edema
* Ulceration
* Fever
* Infection
* Sepsis
* Septicemia
* Recurrent dysphagia
* Fistula formation
* Tracheal compression/obstruction (or acute airway compression)
* Hematemesis
* Death (other than that due to normal disease progression)
* Stent fracture
* Retrosternal Pain
* Stent Fracture (Invagination)
Possible complications after stent removal
* Bleeding
* Ulceration
* Perforation
* Pain
* Stent fracture
Possible Post stent Complications
* Sensitivity to the metal component of the stent
* Mediastinitis
* Aspiration
* Intestinal obstruction (secondary to stent migration)
* Granulation of tissue around stent ends
Possible complications after Bougie Dilation are perforation, bleeding and pain
(retrosternal).
Based on prior BSC*s clinical studies and collected reports in literature
to-date, the risk-to-benefit ratio is within reason for foreseeable risks.
However, literature reports do not always capture all side effects. Observation
and follow-up of subjects is required as outlined in the protocol.
Boston Scientific Way 100
Marlborough 01752
US
Boston Scientific Way 100
Marlborough 01752
US
Listed location countries
Age
Inclusion criteria
- Esophageal anastomotic stricture post esophagectomy (esophagogastric strictures).
- Esophagectomy performed at the same institution where patient enrollment is planned.
- Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline.
- Inability of passing a standard scope (approx. 9.8 mm diameter).
- Between two and five bougie dilations to at least 16 mm in diameter prior since esophagectomy.
- Age 18 years or older.
- Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.
Exclusion criteria
- Stricture within 2 cm of the upper esophageal sphincter.
- Dysphagia related to motility disorder.
- Non-anastomotic esophageal strictures (including Schatzki Ring).
- Esophagocolonic strictures.
- Planned adjuvant chemo-radiation therapy post esophagectomy.
- Prior esophageal stent placements post esophagectomy.
- Underlying Barrett*s esophagus.
- 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, drug, or biologic within 3 months prior to enrollment in this study.
- Investigator discretion.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01699542 |
| CCMO | NL39686.041.12 |