Clinical trial NCT05564143: Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction
Official title: Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction: A Multi-centered Prospective Randomized Controlled Trial (ENCOURAGE Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Gastric Outlet Obstruction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastric outlet obstruction (GOO), defined by a mechanical obstruction of the duodenum, pylorus, or antrum, may result from various diseases. GOO was caused by underlying malignancy in up to 85% of patients, most of which could be attributed to pancreatic cancer. Malignant GOO may increase morbidity, reducing quality of life, and significantly influencing tolerability and efficacy of oncologic treatments. Before the advent of EUS-guided gastroenterostomy (EUS-GE), placement of enteral self-expandable metallic stents (SEMS) or surgical gastroenterostomy (SGE) are the standard of care for many years. The main shortcoming of enteral SEMS placement is recurrent GOO due to tumor ingrowth/overgrowth, which occurs in the majority of patients who survive longer than 6 months. On the other hand, the main limitation of SGE is its invasive nature, especially in such patients with advanced malignancies and poor nutritional status. In addition, SGE is associated with frequent complications, such as perioperative infections and gastroparesis.

EUS-guided gastroenterostomy (EUS-GE) is a novel procedure for palliation of malignant GOO. Several systematic reviews and meta-analysis demonstrated the feasibility, efficacy and safety of EUS-GE. Compared with laparoscopic GE (LGE), EUS-GE not only had almost identical technical and clinical success but also reduced time to oral intake, shorter median hospital stay, and lower rate of adverse events. However, data directly comparing EUS-GE to LGE are limited. We aimed to compare clinical outcomes between EUS-GE and LGE in the palliation of malignant GOO under a randomized setting.


Eligibility criteria: Inclusion Criteria:

1. Consecutive patients ≥ 20 years old
2. Confirmed unresectable distal gastric or duodenal or pancreatico-biliary malignancies
3. Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1
4. Performance status ECOG ≤3

Exclusion Criteria:

1. Unable to give informed consent
2. Prior duodenal metallic stent placement
3. Severe comorbidities precluding the endoscopic procedure or operation
4. Life expectancy of less than 1 month
5. History of gastric surgery
6. Linitus plastic
7. Multiple-level bowel obstruction confirmed on radiographic studies such as small bowel series or abdominal computed tomography
8. Coagulation disorders
9. Pregnancy

Primary outcomes:
measure: Time to functional recovery (days)
timeFrame: 1 week
Secondary outcomes:
measure: Technical success rate
timeFrame: 1 day
measure: Clinical success rate
timeFrame: 1 week
measure: Re-intervention rate
timeFrame: 6 months
measure: Duration of gastroenterostomy patency
timeFrame: 6 months
measure: Adverse events rates
timeFrame: 6 months
measure: Gastric outlet obstruction scores (GOOS)
timeFrame: 6 months
measure: Quality of life assessment scores
timeFrame: 6 months
measure: Quality of life assessment scores
timeFrame: 6 months
Other outcomes:
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