Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810377
Status:
UNKNOWN
Last Update Posted:
2022-07-22
First Post:
2021-02-18
Brief Title:
Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction
Sponsor:
Coordinación de Investigación en Salud Mexico
Organization:
Coordinación de Investigación en Salud Mexico
Study Overview
Official Title:
Safety and Efficacy of Endoscopic Ultrasound-Guided Gastroenterostomy for the Treatment of Malignant Gastric Outlet Obstruction
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 986 97-3 -999 and clinical success of 801 with patency of 1692 1368-2017 days On the other hand the technical success reported for self-expanding metal stents is 962 941 vs 984 technical success is 794 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 0001 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None