Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction

NCT04810377 | Completed DMC

• 1 other identifier: R-2020-3601-298
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Gastric Outlet Obstruction

Keywords

EUS-Guided gastro-enterostomy; Safety; Efficacy

Outcome Measures

Primary Outcomes (5)

• Incidence of immediate adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.

  To evaluate the proportion of patients that presents with bleeding , prostheses misplacement or perforation.

  Adverse events will be recorded during the first 24 hours of the procedure

• Incidence of early-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.

  we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.

  Adverse events will be recorded after the first day up to 30 days of the procedure

• Incidence of mid-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.

  we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.

  Adverse events will be recorded from the first month up to the third month after procedure

• Incidence of long-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.

  we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.

  Adverse events will be recorded after the third month of the stent placement up to study completion, an average of 6 months

• Incidence of the correct stent placement for endoscopic ultrasound gastro-enterostomy anastomosis creation at the desired loop

  Technical success: We will determine the ability to place the stents in the desired loop and in a correct position.

  During each procedure correct stent placement will be assessed

Secondary Outcomes (4)

• Improvement in tolerance to oral feeding assessed by the gastric outlet obstruction scoring system (GOOSS) in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy

  Immediately after the intervention/procedure/surgery and every month through study completion, an average of 6 months

• Changes in quality of life assessed by the self-report health-related quality of life questionnaire in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.

  Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.

• Changes of functional impairment assessed by Karnofsky Performance Scale Index in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.

  Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.

• Changes in functional status with Eastern Cooperative Oncology Group (ECOG) performance scale in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.

  Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.

Study Arms (1)

EUS-guided gastroenterostomy in malignant gastric outlet obstruction

EXPERIMENTAL

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).

Procedure: EUS-guided gastroenterostomy

Interventions

EUS-guided gastroenterostomy PROCEDURE

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.

EUS-guided gastroenterostomy in malignant gastric outlet obstruction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Centro Medico Nacional Siglo XXI Hospital de Especialidades

Mexico City, Mexico City, 06700, Mexico

Location

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Study Officials

• Oscar V Hernández Mondragón, MD

  IMSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a prospective study that evaluates EUS-guided gastroenterostomy in a group of participants with diagnosis of malignant gastric outlet obstruction. Patients are sequentially recruited as diagnosed.

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 23, 2021
• Study Start: January 1, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)