Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction
Mexico40 participantsStarted 2021-01-01
Plain-language summary
Malignant gastric outlet obstruction is a very disabling complication of patients with gastric, duodenal, ampullary, pancreatic, or bile duct cancer and worsens their prognosis. Current treatments have reported a similar complication rate and higher mortality in surgically treated patients. Recently, the creation of endoscopic ultrasound-guided gastroenterostomy (EUS) has shown promising results in these patients. The aim of this research is to determine the safety and efficacy of EUS-guided gastro-enterostomy in the treatment of patients with malignant gastric outlet obstruction.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients of both genders over 18 years of age with gastric outlet obstruction syndrome secondary to stage III or more at gastric, duodenal or pancreatic cancer who are candidates for palliative treatment, who do not want surgical treatment.
* Diagnosis confirmed as follows:
* Histopathological report of cancer.
* Simple and contrasted thoracoabdominal tomography.
* Tolerance to oral feeding based on liquids only or null.
Exclusion Criteria:
* Patients who do not accept the signing of the informed consent.
* Postoperative patients with Roux-en-Y gastrojejunostomy.
* Patients with large volume ascites.
* Patients with malignant obstruction distal to the jejunal puncture.
* Pregnant women.
* Patients with a Karnofsky index less than 50 or an E.C.O.G. greater than or equal to 4 points.
* Patients in whom any endoscopic procedure has been contraindicated for any reason.
* Patients who want to undergo surgical treatment as an initial option.
* Patients with malignant biliary obstruction without endoscopic treatment at the time of gastric outflow tract obstruction presentation.
Elimination Criteria:
* Patients who undergo the endoscopic procedure but cannot be completed due to transmural invasion of malignancy, hemorrhage or inability to puncture the intestinal loop with any method described, puncture site\> 2cm away from the gastric wall or inability to pass the guidewire through obstruction (unless direct technique is per…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of immediate adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Timeframe: Adverse events will be recorded during the first 24 hours of the procedure
2
Incidence of early-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Timeframe: Adverse events will be recorded after the first day up to 30 days of the procedure
3
Incidence of mid-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Timeframe: Adverse events will be recorded from the first month up to the third month after procedure
4
Incidence of long-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Timeframe: Adverse events will be recorded after the third month of the stent placement up to study completion, an average of 6 months
5
Incidence of the correct stent placement for endoscopic ultrasound gastro-enterostomy anastomosis creation at the desired loop
Timeframe: During each procedure correct stent placement will be assessed
Trial details
NCT IDNCT04810377
SponsorCoordinación de Investigación en Salud, Mexico