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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04660695
Other study ID # PI152-19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 15, 2019
Est. completion date May 12, 2021

Study information

Verified date May 2021
Source Hospital del Río Hortega
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Gastric outlet obstruction in malignant disease appears when the tumor affects the gastroduodenal area, precluding the passage of food into the small bowel. This condition severely affects the quality of life. In patients with unresectable tumors, there are various available treatments:a surgical bypass connecting the stomach to the small bowel, placing a stent through the tumor to widen the passage and creating a gastrointestinal bypass with a lumen apposing metal stent. These stents are deployed with an echoendoscope, which allows to identify a small bowel loop and to deploy the stent, connecting the small bowel and the stomach. This is called a EUS-guided gastroenterostomy (EUS-GE). EUS-GE is a rather novel procedure. Various techniques to create EUS-GE have been proposed. In this study, the investigators will retrieve data from the procedure and during the thirty following days from consecutive patients undergoing an EUS-GE. The objectives of the study are: - To perform a detailed step by step description of the nasobiliary drain assisted EUS-GE - To describe the adverse events encountered - To describe the proportion of clinical and technical success - To assess its impact on the patients' quality of life. - To assess the evolution of the oral intake during the first month after the procedure


Description:

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Study Design


Intervention

Device:
EUS-guided gastroenterostomy
Firstly, un upper digestive endoscopy is performed with a conventional gastroscope. A guidewire is passed through the malignant lesion causing the gastric outlet obstruction. Once the guidewire is located in the distal duodenum/proximal jejunum, a nasobiliary drain (Nasal Biliary Drainage Sets, Cook medical, Indiana) is advanced over the guidewire until its distal end is placed in the distal duodenum/jejunum. At this point the gastroscope is substituted by a therapeutic echoendoscope. With the echoendoscope in place, the target bowel loop is filled with saline combined with methilene blue and radiopaque contrast. The echoendoscope is used to identify the target bowel loop. AFter identifying the target, a lumen apposing metal stent (Axios, Boston Scientific, Massachusetts) is deployed across the gastric and bowel using its electrocautery enhanced deployment device.

Locations

Country Name City State
India Christian Medical College Vellore
Spain Hospital General Universitario de Alicante Alicante
Spain Clinica Universidad de Navarra Pamplona Navarra
Spain Complejo Hospitalario de Navarra Pamplona Navarra
Spain Hospital Universitario Río Hortega Valladolid

Sponsors (5)

Lead Sponsor Collaborator
Hospital del Río Hortega Christian Medical College, Vellore, India, Clinica Universidad de Navarra, Universidad de Navarra, Complejo Hospitalario de Navarra, Hospital General Universitario de Alicante

Countries where clinical trial is conducted

India,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Technical Success An adequate stent placement across the GI walls, with one flange in the gastric cavity and the other in the small bowel lumen. It has to be confirmed either fluoroscopically or endoscopically. Day +1
Primary Early Clinical Success Defined as a GOOSS >=2. Day +7
Primary Clinical Success Defined as a GOOSS >=2. Day +30
Secondary Baseline Gastric outlet obstruction score system (GOOSS) The GOOSS is a previously defined classification of Gastric outlet obstruction which incudes 4 categories (0-Nil Per Os; 1 liquids only; 2 soft diet; 3 low residue or full diet) Baseline
Secondary Early Gastric outlet obstruction score system (GOOSS) The GOOSS is a previously defined classification of Gastric outlet obstruction which incudes 4 categories (0-Nil Per Os; 1 liquids only; 2 soft diet; 3 low residue or full diet) day +7
Secondary Final Gastric outlet obstruction score system (GOOSS) The GOOSS is a previously defined classification of Gastric outlet obstruction which incudes 4 categories (0-Nil Per Os; 1 liquids only; 2 soft diet; 3 low residue or full diet) day +30
Secondary Baseline European Organisation for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30) The EORTC-QLQ-C30 is a validated questionnaire (with validated translations in Spanish), which includes 30 items covering a global health status scale, five functional scales and ten symptom scales Baseline
Secondary Final European Organisation for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30) The EORTC-QLQ-C30 is a validated questionnaire (with validated translations in Spanish), which includes 30 items covering a global health status scale, five functional scales and ten symptom scales Baseline, day+30
Secondary Number of Participants With intraprocedure Treatment-Related Adverse Events as Assessed by the ASGE classification The ASGE classification is a tool developed to describe and assess the severity of endoscopy related adverse events. day+1,
Secondary Number of Participants With Early Treatment-Related Adverse Events as Assessed by the ASGE classification The ASGE classification is a tool developed to describe and assess the severity of endoscopy related adverse events. day+7
Secondary Number of Participants With Delayed Treatment-Related Adverse Events as Assessed by the ASGE classification The ASGE classification is a tool developed to describe and assess the severity of endoscopy related adverse events. day+30
Secondary Recurrent GOO In patients achieving clinical success in day +7, recurrent GOO is defined as the development of nausea and vomiting and/or a GOOSS<2. Day +30
Secondary Target bowel loop diameter (mm) Diameter measured with the EUS of the dilated bowel loop. It should be measured just before placing the stent Procedure
Secondary Total volume infused (ml) Volume of saline, methilene blue solution or radiopaque contrast solution instiled to dilate the target bowel loop Procedure
Secondary Number of patients undergoing balloon dilation After deploying the stent, it might be dilated with a controlled radial expansion balloon dilator Procedure
Secondary Type of fluid employed Three different fluids can be used to dilate the target bowel loop, saline, methilene blue diluted in saline or radiopaque contrast diluted in saline Procedure
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