Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

Study Overview
=================
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

Official Title
-----------------
Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

Conditions
-----------------
Gastric Outlet Obstruction

Intervention / Treatment
-----------------
* Procedure: Surgical gastrojejunostomy (SGJ)
* Procedure: Endoscopic gastrojejunostomy (EGJ)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomly assigned in a 1:1 ratio to surgical gastrojejunostomy (SGJ) or endoscopic gastrojejunostomy (EGJ).
Masking: None (Open Label)


Arms and Interventions

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

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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 1 year | 
| 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 | 1 year | 
| 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. | 30 Days | 
| Chemotherapeutic regimen tolerance | Ability to tolerate TB approved chemotherapeutic regimen | 30 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric outlet obstruction, GOO, Periampullary malignancy, Periampullary cancer, Surgical gastrojejunostomy, Endoscopic gastrojejunostomy, Gastrojejunostomy, Enteral anastamosis