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EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

Primary Purpose

Gastric Outlet Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lumen-apposing metal stent
Self-expandable metal stent
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Outlet Obstruction focused on measuring Gastroenterostomy, Gastric Outlet Obstruction, Cancer, Endosonography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University
  • The Johns Hopkins HospitalRecruiting
  • NYU Langone Health
  • Columbia University
  • University of North Carolina
  • Wake Forest Baptist UniversityRecruiting
  • The Research Institute of McGill University Health CentreRecruiting
  • Ecuadorian Institute of Digestive Diseases (IECED)Recruiting
  • Asian Institute of GastroenterologyRecruiting
  • Hospital Universitario Rio Hortega

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EUS-guided gastroenterostomy (EUS-GE)

Enteral Stenting (ES)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of gastric outlet obstruction recurrence
Recurrence of nausea, vomiting, and inability to tolerate PO intake up to 3 months after the procedure confirmed either endoscopically and/or radiographically.

Secondary Outcome Measures

Technical success rate
Adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.
Clinical success rate
The improvement of at least 1 point in the gastric outlet obstruction score within 7 days after stent insertion.
Length of procedure
Adverse events rate
Post-procedure length of hospital stay
Reintervention rate for recurrent gastric outlet obstruction
Quality of Life SF-36 questionnaire scoring
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.
Overall survival rate
Time to recurrent gastric outlet obstruction
Gastric Outlet Obstruction Scoring system (GOOSS)
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
Stent Dysfunction Rate
the restenosis of the stent due to tumor ingrowth or overgrowth, stent migration, or fracture
Duration of stent patency
Calculated from the time of stent placement to the time of stent dysfunction

Full Information

First Posted
August 15, 2017
Last Updated
October 3, 2023
Sponsor
Johns Hopkins University
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03259763
Brief Title
EUS-GE vs ES for Palliation of Gastric Outlet Obstruction
Official Title
EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Boston Scientific Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Outlet Obstruction
Keywords
Gastroenterostomy, Gastric Outlet Obstruction, Cancer, Endosonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly allocated with a 1:1 ratio to one of the study arms (EUS-GE or ES)
Masking
Participant
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EUS-guided gastroenterostomy (EUS-GE)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Enteral Stenting (ES)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lumen-apposing metal stent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Self-expandable metal stent
Intervention Description
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 Measure Information:
Title
Rate of gastric outlet obstruction recurrence
Description
Recurrence of nausea, vomiting, and inability to tolerate PO intake up to 3 months after the procedure confirmed either endoscopically and/or radiographically.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Technical success rate
Description
Adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.
Time Frame
Day of procedure
Title
Clinical success rate
Description
The improvement of at least 1 point in the gastric outlet obstruction score within 7 days after stent insertion.
Time Frame
1 week
Title
Length of procedure
Time Frame
Day of procedure
Title
Adverse events rate
Time Frame
1 week
Title
Post-procedure length of hospital stay
Time Frame
1 week
Title
Reintervention rate for recurrent gastric outlet obstruction
Time Frame
3 months
Title
Quality of Life SF-36 questionnaire scoring
Description
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.
Time Frame
3 months
Title
Overall survival rate
Time Frame
1 year
Title
Time to recurrent gastric outlet obstruction
Time Frame
3 months
Title
Gastric Outlet Obstruction Scoring system (GOOSS)
Description
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
Time Frame
1 year
Title
Stent Dysfunction Rate
Description
the restenosis of the stent due to tumor ingrowth or overgrowth, stent migration, or fracture
Time Frame
3 months
Title
Duration of stent patency
Description
Calculated from the time of stent placement to the time of stent dysfunction
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 18-80 years 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 Life expectancy of less than 3 months based on the endoscopist's opinion 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 One of the two techniques (EUS-GE and ES) cannot be performed (at the discretion of the endoscopist)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mouen A. Khashab, MD
Phone
443-509-3388
Email
mkhasha1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren A Sekela, MPH
Phone
410-502-2811
Email
lsekela1@jh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mouen A. Khashab, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thiruvengadam Muniraj
Email
thiruvengadam.muniraj@yale.edu
First Name & Middle Initial & Last Name & Degree
Thiruvengadam Muniraj
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren A Sekela, MPH
Phone
410-502-2811
Email
lsekela1@jh.edu
First Name & Middle Initial & Last Name & Degree
Mouen A Khashab, MD
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Haber
Email
gregory.haber@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Gregory Haber
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kavel Visrodia
Email
khv2105@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Kavel Visrodia
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Baron
Email
todd_baron@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Todd Baron
Facility Name
Wake Forest Baptist University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rishi Pawa
Email
rpawa@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Rishi Pawa
Facility Name
The Research Institute of McGill University Health Centre
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen-I Chen
Email
yen-i.chen@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Yen-I Chen
Facility Name
Ecuadorian Institute of Digestive Diseases (IECED)
City
Guayaquil
Country
Ecuador
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Robles Medranda
Email
carlosoakm@yahoo.es
First Name & Middle Initial & Last Name & Degree
Carlos Robles Medranda
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sundeep Lakhtakia
Email
drsundeeplakhtakia@gmail.com
First Name & Middle Initial & Last Name & Degree
Sundeep Lakhtakia
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14760669
Citation
Mittal A, Windsor J, Woodfield J, Casey P, Lane M. Matched study of three methods for palliation of malignant pyloroduodenal obstruction. Br J Surg. 2004 Feb;91(2):205-9. doi: 10.1002/bjs.4396.
Results Reference
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PubMed Identifier
15457364
Citation
Johnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. doi: 10.1007/s00268-004-7329-0. Epub 2004 Aug 3.
Results Reference
background
PubMed Identifier
16261429
Citation
Maetani I, Akatsuka S, Ikeda M, Tada T, Ukita T, Nakamura Y, Nagao J, Sakai Y. Self-expandable metallic stent placement for palliation in gastric outlet obstructions caused by gastric cancer: a comparison with surgical gastrojejunostomy. J Gastroenterol. 2005 Oct;40(10):932-7. doi: 10.1007/s00535-005-1651-7.
Results Reference
background
PubMed Identifier
23299137
Citation
Khashab M, Alawad AS, Shin EJ, Kim K, Bourdel N, Singh VK, Lennon AM, Hutfless S, Sharaiha RZ, Amateau S, Okolo PI, Makary MA, Wolfgang C, Canto MI, Kalloo AN. Enteral stenting versus gastrojejunostomy for palliation of malignant gastric outlet obstruction. Surg Endosc. 2013 Jun;27(6):2068-75. doi: 10.1007/s00464-012-2712-7. Epub 2013 Jan 9.
Results Reference
background
PubMed Identifier
26215646
Citation
Khashab MA, Kumbhari V, Grimm IS, Ngamruengphong S, Aguila G, El Zein M, Kalloo AN, Baron TH. EUS-guided gastroenterostomy: the first U.S. clinical experience (with video). Gastrointest Endosc. 2015 Nov;82(5):932-8. doi: 10.1016/j.gie.2015.06.017. Epub 2015 Jul 26.
Results Reference
background
PubMed Identifier
28032663
Citation
Itoi T, Baron TH, Khashab MA, Tsuchiya T, Irani S, Dhir V, Bun Teoh AY. Technical review of endoscopic ultrasonography-guided gastroenterostomy in 2017. Dig Endosc. 2017 May;29(4):495-502. doi: 10.1111/den.12794. Epub 2017 Jan 27.
Results Reference
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PubMed Identifier
27834024
Citation
Chen YI, Itoi T, Baron TH, Nieto J, Haito-Chavez Y, Grimm IS, Ismail A, Ngamruengphong S, Bukhari M, Hajiyeva G, Alawad AS, Kumbhari V, Khashab MA. EUS-guided gastroenterostomy is comparable to enteral stenting with fewer re-interventions in malignant gastric outlet obstruction. Surg Endosc. 2017 Jul;31(7):2946-2952. doi: 10.1007/s00464-016-5311-1. Epub 2016 Nov 10. Erratum In: Surg Endosc. 2017 Jul 17;:
Results Reference
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PubMed Identifier
20189503
Citation
Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
Results Reference
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PubMed Identifier
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Citation
Adler DG, Baron TH. Endoscopic palliation of malignant gastric outlet obstruction using self-expanding metal stents: experience in 36 patients. Am J Gastroenterol. 2002 Jan;97(1):72-8. doi: 10.1111/j.1572-0241.2002.05423.x.
Results Reference
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EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

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