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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04810377
Study type Interventional
Source Coordinación de Investigación en Salud, Mexico
Contact Oscar V Hernández Mondragón, MD
Phone +525556276900
Email mondragonmd@yahoo.co.uk
Status Recruiting
Phase N/A
Start date January 1, 2021
Completion date December 1, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05564143 - Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction N/A
Recruiting NCT06128018 - Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO. N/A
Withdrawn NCT04375462 - AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients N/A
Recruiting NCT02440724 - The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents N/A
Recruiting NCT05986890 - Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction N/A