Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction
NCT ID: NCT04810377
Last Updated: 2025-04-24
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-01-01
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EUS-guided gastroenterostomy in malignant gastric outlet obstruction
The patients with malignant gastric outlet obstruction will be confirmed as follows: Histopathological report of cancer, thoracoabdominal tomography and impaired tolerance to oral feeding (tolerance to liquids only or null).
EUS-guided gastroenterostomy
First after an upper endoscopy is performed, a catheters passed throughout the endoscope channel and with x-ray verification, a guide wire is passed up to the third portion of duodenal loop. then small intestinal is filled with saline solution up to 1500cc and contrast solution. Then an endoscopic ultrasound examination will be carried out where a loop of the small intestine that is located less than 2 cm apart from the gastric wall will be looked for. Once the intestinal loop is identified a direct antegrade puncture will be performed with a luminal apposition prosthesis release system . Finally, correct position is verified with x-ray and we will look for any misplacement or leakage during this process or the presence of bleeding. Endoscopic treatment will be performed if necessary. Subsequently, the participants will go to monthly follow-up with clinical evaluation, laboratory and radiological test will be carried out until the participants dies.
Interventions
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EUS-guided gastroenterostomy
First after an upper endoscopy is performed, a catheters passed throughout the endoscope channel and with x-ray verification, a guide wire is passed up to the third portion of duodenal loop. then small intestinal is filled with saline solution up to 1500cc and contrast solution. Then an endoscopic ultrasound examination will be carried out where a loop of the small intestine that is located less than 2 cm apart from the gastric wall will be looked for. Once the intestinal loop is identified a direct antegrade puncture will be performed with a luminal apposition prosthesis release system . Finally, correct position is verified with x-ray and we will look for any misplacement or leakage during this process or the presence of bleeding. Endoscopic treatment will be performed if necessary. Subsequently, the participants will go to monthly follow-up with clinical evaluation, laboratory and radiological test will be carried out until the participants dies.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Coordinación de Investigación en Salud, Mexico
OTHER_GOV
Responsible Party
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Principal Investigators
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Oscar V Hernández Mondragón, MD
Role: PRINCIPAL_INVESTIGATOR
IMSS
Locations
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Centro Medico Nacional Siglo XXI Hospital de Especialidades
Mexico City, Mexico City, Mexico
Countries
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References
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Other Identifiers
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R-2020-3601-298
Identifier Type: -
Identifier Source: org_study_id
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