Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction

Coordinación de Investigación en Salud, Mexico

Status: Completed

Conditions: Malignant Gastric Outlet Obstruction

Treatments: Procedure: EUS-guided gastroenterostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04810377

R-2020-3601-298

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

EUS-guided gastroenterostomy in malignant gastric outlet obstruction

Experimental group

Description:

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).

Treatment:

Procedure: EUS-guided gastroenterostomy