None listed
Conditions
Brief summary
This study aims to compare the efficacy of two types of Self-Expandable Metallic Stents (SEMS) in the treatment of gastric malignancies. Who is it for? The study is looking for participants that are required to have stents inserted for treatment of malignant gastric outlet obstruction (or “GOO”). Purpose of the study Self-Expandable Metallic Stent (or SEMS) are placed to open a stricture or tightening within the small bowel that is causing your symptoms, as food cannot pass through from the stomach into the small bowel. Uncovered stents (U-SEMS) are often placed to open this but there is the risk of tumour growing into the stent. When the stent is covered (C-SEMS), the tumour cannot grow into the stent. However, there is the risk of the stent moving (migrating). Though there have been multiple studies assessing the difference between C-SEMS and U-SEMS, and there are both advantages and disadvantages to using either, newer comparison studies are needed, as the introduction of recent technological developments have allowed for better SEMS fixation it is not clear which type of technique is preferred. Study Details We aim to compare the differences of two types of Self-Expandable Metallic Stents (SEMS) for GOO relief: • “Covered” SEMS (C-SEMS), and • “Uncovered” SEMS (U-SEMS). These two types will be assessed in terms of stent patency, technical success, clinical success, and safety. These will be assessed at the day of the procedure, and three follow-up visits. We are particularly interested in comparing the stent patency rate between groups; the percentage of participants with stents that do not require re-intervention at 3- and 6-months post placement.
Interventions
Participants will be randomised, in 1:1 ratio, to receive either:
i) “Covered” stent (C-SEMS), the comparator group; or
ii) “Uncovered” stent (U-SEMS), the intervention group.
for treatment of malignant gastric outlet obstruction.
Stent insertion will occur via endoscopic procedure by an endoscopist. Mode of sedation will be as per anaesthetic team. A therapeutic endoscope (3.7mm working channel) approaches the gastric or duodenal stenosis site. A guidewire and catheter was then passed through
Participants will be randomised, in 1:1 ratio, to receive either: i) “Covered” stent (C-SEMS), the comparator group; or ii) “Uncovered” stent (U-SEMS), the intervention group. for treatment of malignant gastric outlet obstruction. Stent insertion will occur via endoscopic procedure by an endoscopist. Mode of sedation will be as per anaesthetic team. A therapeutic endoscope (3.7mm working channel) approaches the gastric or duodenal stenosis site. A guidewire and catheter was then passed through the stenosis and distally, with endoscopic and fluoroscopic guidance. Using a balloon, the stenosis length is approximated. With consideration for shortening of the stent after extension a SEMS of appropriate length is chosen (6/9/12mm). The SEMS is then placed under endoscopic and fluoroscopic guidance. A Stenting procedure is expected to take approximately 1 hour. Patients will be followed up at 1-month, 3-month, and 6-month timepoints, via on-site visits with investigators, and consulting patient medical and surgical records.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients required to have stents inserted for treatment of malignant gastric outlet obstruction (mGOO, defined as patients with malignant Gastric Outlet Obstruction Scoring System (GOOSS) of <2).
Exclusion criteria
Prior metallic stent placement Prior gastric surgery Pregnancy Eastern Cooperative Oncology Group (ECOG) score >3 Severe comorbidities precluding endoscopic procedure Life expectancy of less than 1 month Unable to provide informed consent
Outcome results
None listed