Endoscopy, Digestive System, EUS Guided Enteroenteric Anastomosis, Gastric Outlet Obstruction Due to Malignancy
Conditions
Brief summary
Gastric outlet obstruction (GOO) refers to a mechanical blockage of the distal stomach or duodenum that prevents normal passage of food and liquids. According to literature, 50-80% of GOO cases are caused by malignant tumors compressing or directly invading the gastrointestinal tract. Among patients with pancreatic cancer, 15-20% develop GOO \[1,2\]. GOO is also considered a poor prognostic factor in malignancy, with a median survival time of only 3-6 months \[3\]. Traditionally, management options for GOO include surgical gastrojejunostomy and endoscopic enteral metal stent (ES) placement. Endoscopic approaches are less invasive, allow earlier oral intake, and reduce hospital stay \[4-6\]. Considering that most patients with malignant GOO are debilitated, a less invasive option is often preferable. In recent years, endoscopic ultrasound-guided gastroenterostomy (EUS-GE) has emerged as an alternative. A recent systematic review and meta-analysis comparing ES and EUS-GE found similar technical and clinical success rates, but significantly lower re-intervention rates in the EUS-GE group \[7\]. However, most existing studies are retrospective and lack systematic, prospective follow-up data comparing the two approaches remain lacking. This study aims to prospectively evaluate and compare the short- and long-term outcomes-including stent function, oral intake, nutritional status, and quality of life-of patients with malignant GOO undergoing either EUS-GE or conventional enteral stenting.
Interventions
PROCEDUREEndoscopic ultrasound-guided gastroenterostomy
This procedure was performed under general anesthesia with endotracheal intubation. After identifying the site and extent of the obstruction similar with ES, a 7Fr nasobiliary drain was advanced over the guidewire into the target jejunum under fluoroscopic guidance. A linear echoendoscope was then advanced into the stomach to visualize the jejunum. The jejunal loop was adequately distended by continuously infusing a mixture of saline, contrast medium, and indigo carmine using a standard water pump. Once the target jejunum was confirmed, an antispasmodic was administered. Using the freehand technique, the gastric and jejunal walls were directly punctured with an electrocautery- enhanced LAMS (Hot AXIOS, 20 mm diameter, 10 mm length; Boston Scientific). The LAMS was deployed under EUS and fluoroscopic guidance-first the distal flange into the jejunum, followed by intrachannel release of the proximal flange within the echoendoscope, and then its advancement outside the working channel.
Sponsors
National Taiwan University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive patients aged 18 years or older who underwent ES or EUS-GE for unresectable mGOO were enrolled
Exclusion criteria
* Prior enteral stent placement * Multi-level bowel obstruction, * Linitis plastica of the stomach * A life expectancy of less than one mont * Uncorrected coagulopathy * Pregnancy * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reintervention rate | one year | Defined as the need for additional endoscopic treatment due to recurrent GOO symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | one year | Successful stent placement across or bypass the obstruction, confirmed by endoscopy or fluoroscopy |
| Clinical success | one year | 1. ≥ 2 point improvement in the gastric outlet obstruction score (GOOS) after stent insertion; 2. GOOS categorized oral intake into four levels (the minimum and maximum score from 0 to 3): 0 (fasting), 1 (liquid diet), 2 (soft diet), and 3 (normal/low-residue diet). |
| Gastric outlet obstruction score (GOOS) changes | one year | 1. GOOS categorized oral intake into four levels (the minimum and maximum score from 0 to 3): 0 (fasting), 1 (liquid diet), 2 (soft diet), and 3 (normal/low-residue diet). 2. Comparison the GOOS change before and after stent placement (GOOS recored while the patients was discharge) |
| Adverse events (AEs) | one year | AEs, including stent misdeployement, perforation, and bleeding, were classified and graded according to the Adverse Events in GI Endoscopy (AGREE) classification, with a 30-day cut-off distinguishing early and late events. |
| Survival | one year | alive until the last follow-up |
Countries
Taiwan
Outcome results
None listed