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Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy (EAT-GO)

Primary Purpose

Gastric Outlet Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgical gastrojejunostomy (SGJ)
Endoscopic gastrojejunostomy (EGJ)
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Outlet Obstruction focused on measuring Gastric outlet obstruction, GOO, Periampullary malignancy, Periampullary cancer, Surgical gastrojejunostomy, Endoscopic gastrojejunostomy, Gastrojejunostomy, Enteral anastamosis

Eligibility Criteria

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

Inclusion Criteria:

  1. Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer
  2. Symptoms of gastric outlet obstruction (at least 2 of 4 required):

    1. post prandial vomiting,
    2. abdominal pain,
    3. inability to tolerate PO,
    4. imaging consistent with GOO
  3. Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)
  4. Age >18 years old
  5. Life expectancy greater than 2 months or failed duodenal stenting
  6. Surgical Candidate/Tolerate General Anesthesia
  7. Unresectable or metastatic disease

Exclusion Criteria:

  1. Age< 18 years old
  2. Pregnancy
  3. Intestinal obstruction distal to the Ligament of Treitz
  4. Evidence of other luminal strictures of the GI tract
  5. Previous gastric or periampullary surgery
  6. Inability to complete quality of life surveys (QOLS)
  7. Presence of abdominal ascites

Sites / Locations

  • North Shore University HospitalRecruiting
  • Long Island Jewish Medical CenterRecruiting
  • Lenox Hill HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgical gastrojejunostomy (SGJ)

Endoscopic gastrojejunostomy (EGJ)

Arm Description

An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.

A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure.

Outcomes

Primary Outcome Measures

Time to initiation of solid oral intake without symptoms of GOO
Days to initiation of solid oral intake will be measured from randomization to first day of intake of soft solid foods, as indicated by a GOOSS score of 2

Secondary Outcome Measures

Safety of procedure
All adverse events (AEs) occurring after treatment will be graded according to ASGE lexicon. A subject will be considered to have had an adverse event if they had one or more adverse events, and they will be considered to have had a serious adverse event (SAE) if they had one or more serious adverse events
Technical success of procedure
Technical success is defined as adequate deployment and positioning of the stent(s) for EGJ or technical possibility to create an anastomosis for SGJ.
Clinical success of procedure
Clinical success is defined as improvement to a GOOSS score of 2 or 3 (oral intake of soft solid foods or resumption of full diet) without additional intervention.
Time to discharge
Length of stay will be measured from randomization to discharge alive. All patients will be followed until discharge. Patients who die in hospital will be considered censored and time from randomization to death will be used.
Change in BMI
BMI will be measured immediately prior to the procedure, and at one month and three months after the procedure.
Change in albumin levels
Albumin levels will be measured immediately prior to the procedure, and at one month and three months after the procedure.
Change in Gastric Outlet Obstruction Symptom Score (GOOSS)
The Gastric Outlet Obstruction Symptom Score (GOOSS) scale is as follows, whereas a score of 1 is the worst and a score of 4 is the best: Inadequate or no oral intake Liquids/thickened liquids Semisolids/ low residue Unmodified GOOSS will be recorded at each of the following timepoints: immediately prior to the procedure immediately post-procedure 1-day post-procedure 2-days post-procedure 3-days post-procedure 4-days post-procedure 7-days post-procedure, 30-days post-procedure 3-months post-procedure 6-months post-procedure 1-year post-procedure
Change in Gut Function Score (GFS)
Gut Function Score (GFS) scale is as follows, whereas a score of 1 is the worst and a score of 3 is the best: 0. Profuse vomiting Nausea and occasional vomiting Nausea only Normal gut function GFS will be recorded at each of the following timepoints: Immediately prior to the procedure Immediately post-procedure 1-day post-procedure 2-days post-procedure 3-days post-procedure 4-days post-procedure 7-days post-procedure, 30-days post-procedure 3-months post-procedure 6-months post-procedure 1-year post-procedure
Karnofsky Performance Scale (KPS)
Karnofsky Performance Scale is measured on a scale of 0 to 100 as follows, with a score of 0 being the worst and a score of 100 being the best: 100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of their personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent. 20 - Very sick; hospital admission necessary; active supportive treatment necessary. 10 - Moribund; fatal processes progressing rapidly. 0 - Dead KPS will be recorded pre-procedure and at 30-days post-procedure.
Chemotherapeutic regimen tolerance
Ability to tolerate TB approved chemotherapeutic regimen

Full Information

First Posted
September 13, 2022
Last Updated
December 20, 2022
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT05561907
Brief Title
Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
Acronym
EAT-GO
Official Title
Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment
Detailed Description
After potential subjects are screened from the physicians' schedules, they will be assessed for further inclusion criteria. They will be presented with the informed consent form for their review. Once they have been given the opportunity to review and ask questions, they will sign the consent form and from this point will be considered enrolled into the study. After signing the informed consent, subjects will be randomized to one of the two cohorts in a 1:1 manner. On the day of their assigned procedures, subjects will be asked several quality of life questionnaires to obtain a baseline status. Data will be collected during and immediately following the procedure to assess for any possible adverse events. Follow-up data will be completed at the following timepoints: 1-day, 2-day, 3-day, 4-day, and 7-day, 30-day, 3-month, 6-month, and 1-year post-procedure. QOL Scoring Systems GOOSS- Gastric Outlet Obstruction Symptom Score 1 Inadequate or no oral intake 2 Liquids/thickened liquids 3 Semisolids/ low residue 4 unmodified GFS- Gut Function Score from Lowe et al 2002 0 Profuse vomiting 1 Nausea and occasional vomiting 2 Nausea only 3 Normal gut function Pre-Procedure Variables to Record Demographic Gender Weight BMI Cancer Type Clinical Parameters GOOSS Gut Function Score Karnofsky Performance Scale Procedural Parameters EUS-GJ: presence of ascites, able to pass scope beyond obstruction, use of wire to stabilize position, Length of procedure, intraprocedural AEs, Stent size used, successful completion of procedure Laparoscopic GJ: presence of ascites, length of procedure, intraprocedural AEs, conversion to open GJ, successful completion of procedure Post-procedure Hospitalization Daily Function GOOSS Gut Function Score Time to initiation of oral intake liquids Time to initiation of oral intake solids Time to discharge Post procedural AEs 30 Day Outcomes GOOSS Gut Function Score Karnofsky Performance Scale Weight/BMI Able to tolerate TB approved chemotherapeutic regimen

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Outlet Obstruction
Keywords
Gastric outlet obstruction, GOO, Periampullary malignancy, Periampullary cancer, Surgical gastrojejunostomy, Endoscopic gastrojejunostomy, Gastrojejunostomy, Enteral anastamosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomly assigned in a 1:1 ratio to surgical gastrojejunostomy (SGJ) or endoscopic gastrojejunostomy (EGJ).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical gastrojejunostomy (SGJ)
Arm Type
Active Comparator
Arm Description
An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.
Arm Title
Endoscopic gastrojejunostomy (EGJ)
Arm Type
Experimental
Arm Description
A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure.
Intervention Type
Procedure
Intervention Name(s)
Surgical gastrojejunostomy (SGJ)
Intervention Description
Laparoscopic gastrojejunostomy
Intervention Type
Procedure
Intervention Name(s)
Endoscopic gastrojejunostomy (EGJ)
Intervention Description
Endoscopic ultrasound (EUS) guided gastrojejunostomy
Primary Outcome Measure Information:
Title
Time to initiation of solid oral intake without symptoms of GOO
Description
Days to initiation of solid oral intake will be measured from randomization to first day of intake of soft solid foods, as indicated by a GOOSS score of 2
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety of procedure
Description
All adverse events (AEs) occurring after treatment will be graded according to ASGE lexicon. A subject will be considered to have had an adverse event if they had one or more adverse events, and they will be considered to have had a serious adverse event (SAE) if they had one or more serious adverse events
Time Frame
1 year
Title
Technical success of procedure
Description
Technical success is defined as adequate deployment and positioning of the stent(s) for EGJ or technical possibility to create an anastomosis for SGJ.
Time Frame
1 year
Title
Clinical success of procedure
Description
Clinical success is defined as improvement to a GOOSS score of 2 or 3 (oral intake of soft solid foods or resumption of full diet) without additional intervention.
Time Frame
1 year
Title
Time to discharge
Description
Length of stay will be measured from randomization to discharge alive. All patients will be followed until discharge. Patients who die in hospital will be considered censored and time from randomization to death will be used.
Time Frame
1 year
Title
Change in BMI
Description
BMI will be measured immediately prior to the procedure, and at one month and three months after the procedure.
Time Frame
3 months
Title
Change in albumin levels
Description
Albumin levels will be measured immediately prior to the procedure, and at one month and three months after the procedure.
Time Frame
3 months
Title
Change in Gastric Outlet Obstruction Symptom Score (GOOSS)
Description
The Gastric Outlet Obstruction Symptom Score (GOOSS) scale is as follows, whereas a score of 1 is the worst and a score of 4 is the best: Inadequate or no oral intake Liquids/thickened liquids Semisolids/ low residue Unmodified GOOSS will be recorded at each of the following timepoints: immediately prior to the procedure immediately post-procedure 1-day post-procedure 2-days post-procedure 3-days post-procedure 4-days post-procedure 7-days post-procedure, 30-days post-procedure 3-months post-procedure 6-months post-procedure 1-year post-procedure
Time Frame
1 year
Title
Change in Gut Function Score (GFS)
Description
Gut Function Score (GFS) scale is as follows, whereas a score of 1 is the worst and a score of 3 is the best: 0. Profuse vomiting Nausea and occasional vomiting Nausea only Normal gut function GFS will be recorded at each of the following timepoints: Immediately prior to the procedure Immediately post-procedure 1-day post-procedure 2-days post-procedure 3-days post-procedure 4-days post-procedure 7-days post-procedure, 30-days post-procedure 3-months post-procedure 6-months post-procedure 1-year post-procedure
Time Frame
1 year
Title
Karnofsky Performance Scale (KPS)
Description
Karnofsky Performance Scale is measured on a scale of 0 to 100 as follows, with a score of 0 being the worst and a score of 100 being the best: 100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of their personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent. 20 - Very sick; hospital admission necessary; active supportive treatment necessary. 10 - Moribund; fatal processes progressing rapidly. 0 - Dead KPS will be recorded pre-procedure and at 30-days post-procedure.
Time Frame
30 Days
Title
Chemotherapeutic regimen tolerance
Description
Ability to tolerate TB approved chemotherapeutic regimen
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer Symptoms of gastric outlet obstruction (at least 2 of 4 required): post prandial vomiting, abdominal pain, inability to tolerate PO, imaging consistent with GOO Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only) Age >18 years old Life expectancy greater than 2 months or failed duodenal stenting Surgical Candidate/Tolerate General Anesthesia Unresectable or metastatic disease Exclusion Criteria: Age< 18 years old Pregnancy Intestinal obstruction distal to the Ligament of Treitz Evidence of other luminal strictures of the GI tract Previous gastric or periampullary surgery Inability to complete quality of life surveys (QOLS) Presence of abdominal ascites
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Molly Stewart
Phone
718-470-4667
Email
mstewart8@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hye Jeong Jang
Phone
718-470-7983
Email
hjang3@northwell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petros Benias, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arvind Trindade, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Stewart
Phone
718-470-4667
Email
mstewart8@northwell.edu
First Name & Middle Initial & Last Name & Degree
Hye Jeong Jang
Phone
718-470-7983
Email
hjang3@northwell.edu
First Name & Middle Initial & Last Name & Degree
Matthew Weiss, MD
First Name & Middle Initial & Last Name & Degree
Sandeep Anantha, MD
First Name & Middle Initial & Last Name & Degree
John Wang, MD
First Name & Middle Initial & Last Name & Degree
Arvind Trindade, MD
First Name & Middle Initial & Last Name & Degree
Petros Benias, MD
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Stewart
Phone
718-470-4667
Email
mstewart8@northwell.edu
First Name & Middle Initial & Last Name & Degree
Hye Jeong Jang
Phone
718-470-7983
Email
hjang3@northwell.edu
First Name & Middle Initial & Last Name & Degree
Arvind Trindade, MD
First Name & Middle Initial & Last Name & Degree
Petros Benias, MD
First Name & Middle Initial & Last Name & Degree
Matthew Weiss, MD
First Name & Middle Initial & Last Name & Degree
Sandeep Anantha, MD
First Name & Middle Initial & Last Name & Degree
John Wang, MD
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Stewart
Phone
718-470-4667
Email
mstewart8@northwell.edu
First Name & Middle Initial & Last Name & Degree
Hye Jeong Jang
Phone
718-470-7983
Email
hjang3@northwell.edu
First Name & Middle Initial & Last Name & Degree
Petros Benias, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
Fan W, Tan S, Wang J, Wang C, Xu H, Zhang L, Liu L, Fan Z, Tang X. Clinical outcomes of endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction: a systematic review and meta-analysis. Minim Invasive Ther Allied Technol. 2022 Feb;31(2):159-167. doi: 10.1080/13645706.2020.1792500. Epub 2020 Jul 16.
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Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

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