Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction

Malignant Gastric Outlet Obstruction Clinical Trial

Official title:

Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction: A Multi-centered Prospective Randomized Controlled Trial (ENCOURAGE Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05564143
• Other study ID #: 202204110RIPA
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2022
• Source: National Taiwan University Hospital
• Contact: Yu-Ting Kuo, MD, MSc
• Phone: +886-223123456
• Email: sfstruck[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Malignant Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Procedure:
• EUS-guided gastroenterostomy (EUS-GE)
Treatment
• Laparoscopic gastroenterostomy (LGE)
Treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week
Secondary	Technical success rate	The successful gastroenterostomy was confirmed by endoscopy or operation	1 day
Secondary	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	1 week
Secondary	Re-intervention rate	The percentage of patients requiring additional endoscopic intervention due to stent dysfunction	6 months
Secondary	Duration of gastroenterostomy patency	Calculated from the time of gastroenterostomy creation to the time of gastroenterostomy dysfunction	6 months
Secondary	Adverse events rates	Graded according to the lexicon of endoscopic adverse events	6 months
Secondary	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	6 months
Secondary	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.	6 months
Secondary	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.	6 months