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

NCT04660695 | Completed DMC FDA Device

• 1 other identifier: PI152-19
• Study Type: observational
• Target: 66
• Locations: 2 countries
• Sites: 5

Brief 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

Gastric Outlet Obstruction; Gastric Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• Early Clinical Success

  Defined as a GOOSS \>=2.

  Day +7

• Clinical Success

  Defined as a GOOSS \>=2.

  Day +30

Secondary Outcomes (13)

• Baseline Gastric outlet obstruction score system (GOOSS)

  Baseline

• Early Gastric outlet obstruction score system (GOOSS)

  day +7

• Final Gastric outlet obstruction score system (GOOSS)

  day +30

• Baseline European Organisation for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30)

  Baseline

• Final European Organisation for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30)

  Baseline, day+30

Study Arms (1)

Group 1

Patients included will undergo an EUS-guided gastroenterostomy with a 15x10mm or a 20x10mm lumen apposing metal Stent (Axios, Boston Scientific, Mass).

Device: EUS-guided gastroenterostomy

Interventions

EUS-guided gastroenterostomy DEVICE

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.

Also known as: AXIOS™ Stent and Electrocautery Enhanced Delivery System (Boston Scientific, Mass)

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients over 18 years of age submitted to any of the participanting center's endoscopy units to receive a nasobiliary drain assisted EUS-GE for unresectable malignant GOO are eligible to participate in this study. Patients with a previous gastroduodenal surgery, a previous endoscopic or surgical treatment for GOO, a simultaneous malignant biliary obstruction or unable to understand the questionnaires will be excluded.

You may qualify if:

• Patients over 18 years of age
• unresectable malignant gastric outlet obstruction
• Undergoing placement of nasobiliary drain assisted EUS-GE

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital del Rio Hortega: lead
• Hospital General Universitario de Alicante: collaborator
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator
• Complejo Hospitalario de Navarra: collaborator
• Christian Medical College, Vellore, India: collaborator

Study Sites (5)

Christian Medical College

Vellore, India

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario Río Hortega

Valladolid, 47014, Spain

Location

Related Publications (2)

• Chavarria 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 DERIVED

• Garcia-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 DERIVED

MeSH Terms

Conditions

Gastric Outlet Obstruction; Stomach Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Carlos de la Serna Higuera, MD

  Hospital del Rio Hortega

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md PhD

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 9, 2020
• Study Start: August 15, 2019
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

IN (1); ES (4)