Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction

Sponsor

Coordinación de Investigación en Salud, Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT04810377

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Gastric Outlet Obstruction	Procedure: EUS-guided gastroenterostomy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Endoscopic Ultrasound-Guided Gastroenterostomy for the Treatment of Malignant Gastric Outlet Obstruction

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Procedure: 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.

Arm

Intervention/Treatment

Experimental: 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).

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Incidence of immediate adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy. [Adverse events will be recorded during the first 24 hours of the procedure]
To evaluate the proportion of patients that presents with bleeding , prostheses misplacement or perforation.
Incidence of early-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy. [Adverse events will be recorded after the first day up to 30 days of the procedure]
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Incidence of mid-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy. [Adverse events will be recorded from the first month up to the third month after procedure]
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Incidence of long-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy. [Adverse events will be recorded after the third month of the stent placement up to study completion, an average of 6 months]
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Incidence of the correct stent placement for endoscopic ultrasound gastro-enterostomy anastomosis creation at the desired loop [During each procedure correct stent placement will be assessed]
Technical success: We will determine the ability to place the stents in the desired loop and in a correct position.

Secondary Outcome Measures

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]
Clinical success: Defined as an increase in tolerance to oral feeding, assessed by GOOSS: 0 = no/inadequate oral intake, 1 = liquids/thickened liquids, 2 = semisolids/low residue diet, 3 = unmodified diet. A higher score means a better outcome.
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.]
Quality of life will be measured with the short form survey (SF-36 questionnaire). It consists of physical and mental component scores ranging from 0 to 100; a higher scores means a better outcome, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
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.]
The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. The lower scores means worst prognosis: 100-80 means that the patient is able to perform normal activities; 70-50 points means that the patient is unable to work; able to live at home and care for most personal needs, and 40-0 points means that the patient is unable to care for self; requires equivalent of hospital care and disease may be progressing rapidly.
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.]
The ECOG Scale of performance status describes patients functionality. Lower points means best outcomes.0: fully active. 1: Restricted in some physical activities. 2: Capable of all self-care but unable to carry our any work activities, more than 50% of walking hours. 3: limited self-care, confined to bed or chair more tan 50% of walking hours. 4: Completely disabled. Totally confined to bed or chair. 5: Dead.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Medico Nacional Siglo XXI Hospital de Especialidades	Mexico City		Mexico	06700

Sponsors and Collaborators

Coordinación de Investigación en Salud, Mexico

Investigators

Principal Investigator: Oscar V Hernández Mondragón, MD, IMSS

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Coordinación de Investigación en Salud, Mexico

ClinicalTrials.gov Identifier:

NCT04810377

Other Study ID Numbers:

R-2020-3601-298

First Posted:

Mar 23, 2021

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Coordinación de Investigación en Salud, Mexico

EUS-Guided gastro-enterostomy

Safety

Efficacy

Additional relevant MeSH terms:

Gastric Outlet Obstruction

Pyloric Stenosis

Study Results

No Results Posted as of Jul 22, 2022