Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05082948 |
| Other study ID # |
2101223876 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2021 |
| Est. completion date |
March 15, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
West Virginia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
No standard approach currently exists for endoscopic esophageal stent placement, and both
sutured and un-sutured techniques are employed for esophageal stent placement currently. The
primary purpose of this study is to find out if suture fixation of esophageal stents is
superior to non-suture fixated stent placement.
Consecutive patients who are scheduled for esophageal stent placement will be identified as
potential study participants by study personnel and will be approached on the day of the
procedure. Informed consent will be obtained and patients will be randomized into suture
fixation and non-suture fixation groups. Patients in the suture fixation group will have
their esophageal stent secured in location with two endoscopic sutures. Those in the
non-suture fixation group will have no sutures placed. Main study outcome is stent migration,
and rates of stent migration will be compared in the two groups.
Description:
Esophageal stents are commonly placed for both benign and malignant etiologies. Uncovered or
partially covered metal stents are employed for malignant conditions while fully covered
self-expanding metal stents (FC-SEMSs) are generally placed for the management of benign
conditions. FC-SEMSs are also commonly used for managing perforations, fistulae as well as
for palliation of symptoms that result from benign structuring disease. Due to the difficulty
of uncovered stent removal, FC-SEMSs and partially covered self-expanding metal stents
(PC-SEMS) are increasingly utilized for patients with malignancy undergoing neo-adjuvant
chemotherapy. Stent migration remains the most frequently encountered complication and the
main drawback to their use. While some tissue in-growth is expected in the uncovered metal
stents with resulting stability, the silicone coating in covered SEMSs, and to some degree in
partially covered stents prevents ingrowth, resulting in higher rates of stent migration;
rates exceeding 40% are reported in current scientific literature.2 In recent years, suture
fixation of stents has been explored for migration mitigation however data is limited to
retrospective series and real-world practice varies depending on endoscopist expertise and
experience.
The OverStitch Endoscopic Suturing System (Apollo Endosurgery Incorporation, Austin, TX) is
an FDA approved endoscopic suturing system initially designed for closure of gut wall during
NOTES procedures,3 however it is now commonly employed for closing perforations, leaks, and
has recently garnered attention for stent fixation by suturing in place. At West Virginia
University, this device is used, depending on endoscopist preference, to suture esophageal
stents to prevent migration. The Investigators aim to perform a randomized clinical trial of
endoscopic suture fixated and un-sutured stent placement and compare stent migration rates,
technical success, clinical success, and adverse events along with healthcare cost
utilization in the two groups.
A randomized controlled trial will be performed at WVU Ruby Memorial Hospital. Patients who
are scheduled for esophageal stent placement will be identified as potential study
participants by study personnel and will be approached by study personnel on the day of the
procedure. Eligibility will be confirmed, and study procedures will be explained. After
informed consent is obtained, the patient will be randomized to one of the two groups and the
endoscopy will be informed. Each group will consist of 30 patients.
Esophageal stent will be placed in the standard of care fashion by the endoscopists using
standard Olympus gastroscopes. 18 to 23 mm covered self-expanding metal stent will be placed
as per endoscopist preference. After esophageal stent placement, endoscopic suturing will be
performed in cases of patients randomized to suture fixation.
Suture securement of the esophageal stents will be performed using commercially available
devices. All endoscopes, and suturing devices will be used in accordance with appropriate
Directions for Use (DFU) provided by the manufacturer. The OverStitch Endoscopic Suturing
System (Apollo Endosurgery Incorporation, Austin, TX) is an FDA approved endoscopic suturing
system that will be utilized in the suture fixation cohort. Standard scope reprocessing will
be performed as per institutional protocol after use.
Baseline chest radiographs will be obtained within one week of stent placement. Repeat
radiographs to assess the esophageal stents will be obtained at 4-12 weeks after stent
placement or in the event of worsening or new symptoms. Chest Xrays will be assessed by
attending consultant radiologist and stent positioning will be determined by comparison to
local anatomic skeletal landmarks.
All patients will be contacted by the study team by telephone 30 days after procedure to
assess for any ongoing symptoms or adverse events. Information on unplanned visits including
unplanned emergency department visits or inpatient admissions will also be collected.
Electronic health records of patients will be reviewed at 30 days after procedure for
obtaining information on unplanned ED visits, or inpatient visits.
