Clinical trial NCT04810377: Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction
Official title: Safety and Efficacy of Endoscopic Ultrasound-Guided Gastroenterostomy for the Treatment of Malignant Gastric Outlet Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Gastric Outlet Obstruction
Keywords: EUS-Guided gastro-enterostomy
Safety
Efficacy
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2021-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of immediate adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
timeFrame: Adverse events will be recorded during the first 24 hours of the procedure
measure: Incidence of early-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
timeFrame: Adverse events will be recorded after the first day up to 30 days of the procedure
measure: Incidence of mid-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
timeFrame: Adverse events will be recorded from the first month up to the third month after procedure
measure: Incidence of long-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
timeFrame: Adverse events will be recorded after the third month of the stent placement up to study completion, an average of 6 months
measure: Incidence of the correct stent placement for endoscopic ultrasound gastro-enterostomy anastomosis creation at the desired loop
timeFrame: During each procedure correct stent placement will be assessed
Secondary outcomes:
measure: 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
timeFrame: Immediately after the intervention/procedure/surgery and every month through study completion, an average of 6 months
measure: 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.
timeFrame: Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
measure: Changes of functional impairment assessed by Karnofsky Performance Scale Index in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
timeFrame: Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
measure: 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.
timeFrame: Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Medico Nacional Siglo XXI Hospital de Especialidades
Study officials:
affiliation: IMSS
name: Oscar V Hernández Mondragón, MD
role: PRINCIPAL_INVESTIGATOR
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