Clinical trial · Observational
Nasobiliary Drain Assisted EUS-guided Gastroenterostomies in Unresectable Malignant Gastric Outlet Obstruction
Serie de Casos Prospectiva de Gastroenteroanastomosis Guiada Por Ecoendoscopia Para la obstrucción al Vaciado gástrico en Neoplasias Avanzadas Mediante la técnica Del Drenaje Nasobiliar
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Outlet Obstruction | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-guided gastroenterostomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Patients included will undergo an EUS-guided gastroenterostomy with a 15x10mm or a 20x10mm lumen apposing metal Stent (Axios, Boston Scientific, Mass).
- interventionNames
- Device: EUS-guided gastroenterostomy
Primary outcomes (3)
- measure
- Technical Success
- timeFrame
- Day +1
- description
- 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.
- measure
- Early Clinical Success
- timeFrame
- Day +7
- description
- Defined as a GOOSS \>=2.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years of age * unresectable malignant gastric outlet obstruction * Undergoing placement of nasobiliary drain assisted EUS-GE Exclusion Criteria: * Previous gastroduodenal surgery * Previous endoscopic or surgical treatment for gastric outlet obstruction * Simultaneous biliary obstruction (malignant or benign) requiring endoscopic treatment * Simultaneous upper digestive tract disease requiring endoscopic treatment in the same procedure * Unable to understand the questionnaires * Distal bowel obstruction * Ascites grade 2 or superior * Uncorrectable coagulation disorders (INR\>1,5) or severe thrombocytopenia (\<50000 platelets/mm3). * Active, symptomatic SARS-CoV-2 infection
References
Publications (2)
- DERIVEDChavarria C, Martin-Alvarez V, Aparicio JR, Subtil JC, Garcia-Alonso FJ, Vila JJ, Martinez-Moreno B, Busto Bea V, de la Serna-Higuera C, Perez-Miranda M. EUS-guided gastroenterostomy using a parallel enteric tube for luminal distension: Prospective multicenter procedural standardization (with video). Endosc Ultrasound. 2025 May-Jun;14(3):129-136. doi: 10.1097/eus.0000000000000123. Epub 2025 Jun 13. PMID 41584027
- DERIVEDGarcia-Alonso FJ, Chavarria C, Subtil JC, Aparicio JR, Busto Bea V, Martinez-Moreno B, Vila JJ, Martin-Alvarez V, Sanchez-Delgado L, de la Serna-Higuera C, Perez-Miranda M. Prospective multicenter assessment of the impact of EUS-guided gastroenterostomy on patient quality of life in unresectable malignant gastric outlet obstruction. Gastrointest Endosc. 2023 Jul;98(1):28-35. doi: 10.1016/j.gie.2023.02.015. Epub 2023 Feb 18. PMID 36801458