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Nasobiliary Drain Assisted EUS-guided Gastroenterostomies in Unresectable Malignant Gastric Outlet Obstruction

NCT04660695 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2021-05-14

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hospital General Universitario de Alicante

    collaborator OTHER

  • Clinica Universidad de Navarra, Universidad de Navarra

    collaborator OTHER

  • Complejo Hospitalario de Navarra

    collaborator OTHER

  • Christian Medical College, Vellore, India

    collaborator OTHER

  • Hospital del Rio Hortega

    lead OTHER

Principal Investigators

  • Carlos de la Serna Higuera, MD · Hospital del Rio Hortega

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2021-05-12
Completion
2021-05-12
FDA Device
Yes

Countries

  • India
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04660695 on ClinicalTrials.gov