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Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction

Primary Purpose

Malignant Gastric Outlet Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
EUS-guided gastroenterostomy
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Gastric Outlet Obstruction focused on measuring EUS-Guided gastro-enterostomy, Safety, Efficacy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centro Medico Nacional Siglo XXI Hospital de EspecialidadesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EUS-guided gastroenterostomy in malignant gastric outlet obstruction

Arm 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).

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

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
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.
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.
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.
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.

Full Information

First Posted
February 18, 2021
Last Updated
July 21, 2022
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04810377
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Gastric Outlet Obstruction
Keywords
EUS-Guided gastro-enterostomy, Safety, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EUS-guided gastroenterostomy in malignant gastric outlet obstruction
Arm Type
Experimental
Arm 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).
Intervention Type
Procedure
Intervention Name(s)
EUS-guided gastroenterostomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of immediate adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Description
To evaluate the proportion of patients that presents with bleeding , prostheses misplacement or perforation.
Time Frame
Adverse events will be recorded during the first 24 hours of the procedure
Title
Incidence of early-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Description
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Time Frame
Adverse events will be recorded after the first day up to 30 days of the procedure
Title
Incidence of mid-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Description
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Time Frame
Adverse events will be recorded from the first month up to the third month after procedure
Title
Incidence of long-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Description
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Time Frame
Adverse events will be recorded after the third month of the stent placement up to study completion, an average of 6 months
Title
Incidence of the correct stent placement for endoscopic ultrasound gastro-enterostomy anastomosis creation at the desired loop
Description
Technical success: We will determine the ability to place the stents in the desired loop and in a correct position.
Time Frame
During each procedure correct stent placement will be assessed
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Immediately after the intervention/procedure/surgery and every month through study completion, an average of 6 months
Title
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.
Description
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.
Time Frame
Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
Title
Changes of functional impairment assessed by Karnofsky Performance Scale Index in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Description
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.
Time Frame
Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
Title
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.
Description
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.
Time Frame
Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar V Hernández Mondragón, MD
Phone
+525556276900
Ext
21317-8
Email
mondragonmd@yahoo.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Raúl A Zamarripa Mottú, Fellowship
Phone
+528711733190
Email
raulzm735@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar V Hernández Mondragón, MD
Organizational Affiliation
IMSS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Medico Nacional Siglo XXI Hospital de Especialidades
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar V Hernandez Mondragon, MD
Phone
+525556276900
Ext
21317-8
Email
mondragonmd@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Luis F Garcia Contreras, Fellow
Phone
+525529046271
Ext
21317-8
Email
luisgarcont@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction

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