Gastric Outlet Obstruction
Conditions
Keywords
Gastroenterostomy, Gastric Outlet Obstruction, Cancer, Endosonography
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.
Interventions
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.
Sponsors
Johns Hopkins University
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Patients will be randomly allocated with a 1:1 ratio to one of the study arms (EUS-GE or ES)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Gastric Outlet Obstruction Recurrence | 12 months | Defined as percentage of participants with recurrence of nausea, vomiting, and inability to tolerate PO intake up to 12 months after the procedure confirmed either endoscopically and/or radiographically. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate | Day of procedure | Participants with adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically. |
| Participants With Improved Clinical Success Rate | 1 week | Participants with improvement of at least 1 point in the gastric outlet obstruction score range 0-3 (0 as no oral intake to 3 as complete diet) within 7 days after stent insertion. Higher score better. |
| Length of Procedure | Day of procedure | Duration of the procedure (minutes) |
| Participants With Adverse Events | 12 months | Participants with Adverse events based on ASGE Lexicon |
| Post-procedure Length of Hospital Stay | 1 week | Duration of hospitalization following the procedure, measured in days from the date of the procedure to the date of hospital discharge. |
| Reintervention Rate for Recurrent Gastric Outlet Obstruction | 12 months | Reintervention (endoscopic or surgical) for stent dysfunction causing recurrent gastric outlet obstruction |
| Quality of Life SF-36 Questionnaire Scoring | 3 months | 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 | 1 year | Percentage of participants surviving at 12 months after randomization, regardless of cause of death. |
| Time in Days to Recurrent Gastric Outlet Obstruction | 12 months | Time from the procedure to the start of recurrent gastric outlet obstruction symptoms and signs due to stent dysfunction |
Countries
Canada, Ecuador, France, India, Israel, Spain, United States
Contacts
PRINCIPAL_INVESTIGATORMouen A. Khashab, MD
Johns Hopkins University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63 Years |
| Malignancy Diagnosis Duodenal or Ampullary Cancer | 6 Participants |
| Malignancy Diagnosis Gastric Carcinoma | 10 Participants |
| Malignancy Diagnosis Other | 14 Participants |
| Malignancy Diagnosis Pancreatic Cancer | 49 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 50 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 44 / 57 | 45 / 55 |
| other Total, other adverse events | 4 / 57 | 1 / 55 |
| serious Total, serious adverse events | 0 / 57 | 3 / 55 |
Outcome results
None listed