CompletedNot Applicable

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 range18 Years – 90 Years

SexALL

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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…

What they're measuring

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

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

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

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

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

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-04-01

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