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

February 6, 2024 updated by: Petros Benias, Northwell Health
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

Study Overview

Status

Recruiting

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Matthew Weiss, MD
        • Sub-Investigator:
          • Sandeep Anantha, MD
        • Sub-Investigator:
          • John Wang, MD
        • Principal Investigator:
          • Petros Benias, MD
        • Principal Investigator:
          • Arvind Trindade, MD
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Long Island Jewish Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Matthew Weiss, MD
        • Sub-Investigator:
          • Sandeep Anantha, MD
        • Sub-Investigator:
          • John Wang, MD
        • Principal Investigator:
          • Petros Benias, MD
        • Principal Investigator:
          • Arvind Trindade, MD
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Petros Benias, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgical gastrojejunostomy (SGJ)
An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.
Procedure: Surgical gastrojejunostomy (SGJ)
Laparoscopic gastrojejunostomy
Experimental: Endoscopic gastrojejunostomy (EGJ)
A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure.
Procedure: Endoscopic gastrojejunostomy (EGJ)
Endoscopic ultrasound (EUS) guided gastrojejunostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to initiation of solid oral intake without symptoms of GOO
Time Frame: 1 year
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of procedure
Time Frame: 1 year
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
1 year
Technical success of procedure
Time Frame: 1 year
Technical success is defined as adequate deployment and positioning of the stent(s) for EGJ or technical possibility to create an anastomosis for SGJ.
1 year
Clinical success of procedure
Time Frame: 1 year
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.
1 year
Time to discharge
Time Frame: 1 year
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.
1 year
Change in BMI
Time Frame: 3 months
BMI will be measured immediately prior to the procedure, and at one month and three months after the procedure.
3 months
Change in albumin levels
Time Frame: 3 months
Albumin levels will be measured immediately prior to the procedure, and at one month and three months after the procedure.
3 months
Change in Gastric Outlet Obstruction Symptom Score (GOOSS)
Time Frame: 1 year

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:

  1. Inadequate or no oral intake
  2. Liquids/thickened liquids
  3. Semisolids/ low residue
  4. 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
1 year
Change in Gut Function Score (GFS)
Time Frame: 1 year

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

  1. Nausea and occasional vomiting
  2. Nausea only
  3. 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
1 year
Karnofsky Performance Scale (KPS)
Time Frame: 30 Days

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.
30 Days
Chemotherapeutic regimen tolerance
Time Frame: 30 Days
Ability to tolerate TB approved chemotherapeutic regimen
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Petros Benias, MD, Northwell Health
  • Principal Investigator: Arvind Trindade, MD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-1130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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