Clinical trialNACompleted
Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction
Safety and Efficacy of Endoscopic Ultrasound-Guided Gastroenterostomy for the Treatment of Malignant Gastric Outlet Obstruction
- Outcome
- Finished, no results posted
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- 1 January 2021
- Expected end
- 1 April 2025
- Enrollment
- 40 participants
- Sites
- 1
- Primary outcomes
- Incidence of immediate adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.; Incidence of early-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.; Incidence of mid-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.; Incidence of long-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.; Incidence of the correct stent placement for endoscopic ultrasound gastro-enterostomy anastomosis creation at the desired loop
- Sponsor
- Other gov
- Results posted
- No
- Last update
- 24 April 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
Malignant gastric outlet obstruction is a very disabling complication that occurs in 15% to 25% of patients with gastric, duodenal, ampullary, pancreatic, or bile duct cancer and worsens their prognosis. Roux-en-Y gastrojejunostomy is considered the gold standard treatment with technical success of 98.6% (97-3% -99.9%) and clinical success of 80.1% with patency of 169.2 (136.8-201.7) days. On the other hand, the technical success reported for self-expanding metal stents is 96.2% (94.1% vs. 98.4%), technical success is 79.4%, and patency at 6 months was only 57%. However, complications occur in a similar way in both forms of treatment (major complications in 6% and late complications in 17% in both, but mortality is higher in the group treated with Roux-en-Y gastrojejunostomy (29% vs. 17%). , p \<0.001) Recently, the creation of endoscopic ultrasound-guided gastroenterostomy has shown success rates of over 90% in case series, but prospective studies evaluating the safety and efficacy of the procedure are lacking. The aim of this research to determine the safety and efficacy of EUS-guided gastro-enterostomy in the treatment of patients with malignant gastric outlet obstruction.