An interventional study of EUS-guided gastroenterostomy (EUS-GE) and Laparoscopic gastroenterostomy (LGE) in Malignant Gastric Outlet Obstruction, sponsored by National Taiwan University Hospital. Status unknown. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-10-03.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
National Taiwan University Hospital is the lead sponsor of 2,609 studies on the registry; 574 are open to participants now.
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Exclusion Criteria:
All EUS-GE procedures were performed under general anesthesia with endotracheal intubation. A forward-viewing gastroscope or side-viewing duodenoscope is first inserted into the site of the obstruction and a 0.025- or 0.035-inch stiff GW is placed down-stream of the jejunum beyond the obstruction as far as possible. Then, oral enteral tube is placed where the jejunum intended for stent placement under fluoroscopic guidance. After exchanging to EUS endoscope, the target jejunum is visualized by EUS after continuously injection of mixed saline and contrast medium. Finally, the gastrojejunostomy stent is directly advanced from the gastric wall into the target jejunum by AXIOS-EC delivery system.
Procedure: EUS-guided gastroenterostomy (EUS-GE)
All LGE were performed in the operation room with patients under general anesthesia. After CO2 insufflation, 4 to 5 trocars were introduced. Next, the Treitz ligament was identified. An anterior, dorsal laterolateral, or side- to-side isoperistaltic gastroenteric anastomosis was constructed. The exact location of the gastroenteric anastomosis, with regard to the Treitz ligament, varied from 30 to 60 cm.
Procedure: Laparoscopic gastroenterostomy (LGE)
Treatment
Treatment
Time to functional recovery (days)
Functional recovery is reached when all of the following criteria are met: 1) adequate pain control with oral analgesia only, 2) restoration of mobility to an independent level (or to preoperative level if previously impaired, 3) ability to maintain sufficient caloric intake (minimum of 50% required calories), 4) absence of intravenous fluid administration, and 5) no signs of active abdominal infection.
Time frame: 1 week
Technical success rate
The successful gastroenterostomy was confirmed by endoscopy or operation
Time frame: 1 day
Clinical success rate
Clinical success if measured by the improvement of at least 1 point in the gastric outlet obstruction score within one week after gastroenterostomy
Time frame: 1 week
Re-intervention rate
The percentage of patients requiring additional endoscopic intervention due to stent dysfunction
Time frame: 6 months
Duration of gastroenterostomy patency
Calculated from the time of gastroenterostomy creation to the time of gastroenterostomy dysfunction
Time frame: 6 months
Adverse events rates
Graded according to the lexicon of endoscopic adverse events
Time frame: 6 months
Gastric outlet obstruction scores (GOOS)
Scoring system for food intake. Range of score is 0 -3 with 3 being the highest and indicating tolerating full diet
Time frame: 6 months
Quality of life assessment scores
EORTC QLQ-C30. This questionnaire is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of 5 multiitem scales (physical, role, social, emotional and cognitive functioning) and 9 single items (pain, fatigue, financial impact, appetite loss, nausea/vomiting, diarrhea, constipation, sleep disturbance and quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Time frame: 6 months
Quality of life assessment scores
EORTC STO-22 modules. This the gastric cancer module to the QLQ-C30 questionnaire. The questionnaire is composed of 5 multiitem scales (dysphagia, pain, reflux, eating, anxiety) and 4 single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No — There is not a plan to make IPD available
No publications or documents are linked to this record.
Start is estimated for Oct 2022; primary completion for Jul 2024, 21 months later.
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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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