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EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259763
Recruitment Status : Not yet recruiting
First Posted : August 24, 2017
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).

Condition or disease Intervention/treatment Phase
Gastric Outlet Obstruction Device: Lumen-apposing metal stent Device: Self-expandable metal stent Not Applicable

Detailed Description:

In recent years, Enteral Stenting (ES) has commonly been used as the first line management of unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique for palliation of malignant GOO, which has the theoretical potential to minimize the risk for stent occlusion while maintaining the less invasive endoscopic approach. This novel endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby bypassing the occluded lumen. This endoscopic technique has been performed to treat patients with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly decreased risk of recurrent GOO and reinterventions.

Based on the investigator's clinical experience for the last three years and the above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with ES in the management of unresectable malignant gastric outlet obstruction. The investigators hypothesize that EUS-GE is associated with comparable technical and clinical success and safety profile while requiring fewer re-interventions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomly allocated with a 1:1 ratio to one of the study arms (EUS-GE or ES)
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Active Comparator: EUS-guided gastroenterostomy (EUS-GE)
In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.
Device: Lumen-apposing metal stent
In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.

Active Comparator: Enteral Stenting (ES)
In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.
Device: Self-expandable metal stent
In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.




Primary Outcome Measures :
  1. Recurrent gastric outlet obstruction rate [ Time Frame: 1 year ]
    Recurrence of nausea, vomiting, and inability to tolerate PO intake > 2 weeks after the procedure confirmed either endoscopically and/or radiographically. The need for unplanned re-intervention (endoscopic or surgical) to treat recurrent GOO will also be considered a surrogate for recurrent GOO.


Secondary Outcome Measures :
  1. Technical success rate [ Time Frame: Day of procedure ]
    Adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.

  2. Clinical success rate [ Time Frame: Day of procedure ]
    The ability to tolerate at least a full liquid diet without vomiting

  3. Length of procedure [ Time Frame: Day of procedure ]
  4. Adverse events rate [ Time Frame: 1 week ]
  5. Post-procedure length of hospital stay [ Time Frame: 1 week ]
  6. Reintervention rate for recurrent gastric outlet obstruction [ Time Frame: 1 year ]
  7. Quality of Life SF-36 questionnaire scoring [ Time Frame: 1 month ]
    The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.

  8. Overall survival rate [ Time Frame: 1 year ]
  9. Time to recurrent gastric outlet obstruction [ Time Frame: 1 year ]
  10. Gastric Outlet Obstruction Scoring system (GOOSS) [ Time Frame: 1 year ]

    Diet toleration will be scored based on the Gastric Outlet Obstruction Scoring System (GOOSS). The scoring ranges from 0 to 3 in the following format:

    0 = no oral intake, 1 = liquids only, 2 = soft solids, 3 = low-residue or full diet




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with malignant, symptomatic gastric outlet obstruction due to an unresectable malignant lesion
  • Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only)
  • Age>= 18

Exclusion Criteria:

  • Evidence of other strictures in the gastrointestinal (GI) tract
  • Previous gastric, periampullary or duodenal surgery
  • World Health Organization (WHO) performance score of 4 (patient is 100% of time in bed)
  • Unable to fill out quality of life questionnaire
  • Unable to sign the informed consent
  • Cancer extending into the body of the stomach, 4th portion of the duodenum or proximal jejunum around the ligament of Treitz
  • Large volume ascites
  • Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other severe comorbidities
  • Pregnant or breastfeeding women
  • Uncorrectable coagulopathy defined by INR > 1.5 or platelet < 50000/µl
  • Complete GOO evidenced by inability to either pass a wire across the stricture and/or inability to opacify small bowel distal to the malignant stricture
  • Resectable or borderline resectable tumors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259763


Contacts
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Contact: Mouen A. Khashab, MD 443-509-3388 mkhasha1@jhmi.edu
Contact: Omid Sanaei, MD 410-502-0064 osanaei1@jhmi.edu

Locations
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United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Contact: Omid Sanaei, MD    410-502-0064    osanaei1@jhmi.edu   
Spain
Hospital Universitario Rio Hortega
Valladolid, Spain, 47012
Contact: Francisco Javier Garcia-Alonso    680351234 ext 0034    mailto:fj.garcia.alonso@gmail.com   
Contact: Sergio Bazaga    627995214    mailto:Email%3ASergio.bpr@gmail.com   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Mouen A. Khashab, MD Johns Hopkins University
Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03259763    
Other Study ID Numbers: IRB00128878
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Johns Hopkins University:
Gastroenterostomy
Gastric Outlet Obstruction
Cancer
Endosonography
Additional relevant MeSH terms:
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Gastric Outlet Obstruction
Pyloric Stenosis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases