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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

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

NCT ID

NCT04810377

First Posted

February 18, 2021

Last Updated

July 21, 2022

Sponsor

Coordinación de Investigación en Salud, Mexico

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

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

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

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

mondragonmd@yahoo.co.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Raúl A Zamarripa Mottú, Fellowship

Phone

+528711733190

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

mondragonmd@yahoo.co.uk

First Name & Middle Initial & Last Name & Degree

Luis F Garcia Contreras, Fellow

Phone

+525529046271

Ext

21317-8

luisgarcont@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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Fan W, Tan S, Wang J, Wang C, Xu H, Zhang L, Liu L, Fan Z, Tang X. Clinical outcomes of endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction: a systematic review and meta-analysis. Minim Invasive Ther Allied Technol. 2022 Feb;31(2):159-167. doi: 10.1080/13645706.2020.1792500. Epub 2020 Jul 16.

Results Reference

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PubMed Identifier

25527056

Citation

Barthet M, Binmoeller KF, Vanbiervliet G, Gonzalez JM, Baron TH, Berdah S. Natural orifice transluminal endoscopic surgery gastroenterostomy with a biflanged lumen-apposing stent: first clinical experience (with videos). Gastrointest Endosc. 2015 Jan;81(1):215-8. doi: 10.1016/j.gie.2014.09.039.

Results Reference

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Learn more about this trial

Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction

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