Status:
COMPLETED
Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Malignant Gastric Outlet Obstruction
Eligibility:
All Genders
18-90 years
Phase:
NA
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 hav...
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 prognos...
Eligibility Criteria
Inclusion
- 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
- 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 performed).
- Patients who do not attend follow-up.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04810377
Start Date
January 1 2021
End Date
April 1 2025
Last Update
April 24 2025
Active Locations (1)
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1
Centro Medico Nacional Siglo XXI Hospital de Especialidades
Mexico City, Mexico City, Mexico, 06700