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

Northwell Health

Status: Enrolling

Conditions: Gastric Outlet Obstruction

Treatments: Procedure: Endoscopic gastrojejunostomy (EGJ); Procedure: Surgical gastrojejunostomy (SGJ)

Study type: Interventional

Funder types: Other

Identifiers

NCT05561907

21-1130

Details and patient eligibility

About

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

Full 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

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Surgical gastrojejunostomy (SGJ)

Active Comparator group

Description:

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

Treatment:

Procedure: Surgical gastrojejunostomy (SGJ)

Endoscopic gastrojejunostomy (EGJ)

Experimental group

Description:

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

Treatment:

Procedure: Endoscopic gastrojejunostomy (EGJ)