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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Gastric Outlet Obstruction
• Intervention / Treatment: Procedure: EUS-guided gastroenterostomy (EUS-GE); Procedure: Laparoscopic gastroenterostomy (LGE)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Ting Kuo, MD, MSc; Phone Number: 265587 +886-223123456; Email: sfstruck@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EUS-guided gastroenterostomy (EUS-GE); 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); Treatment
Active Comparator: Laparoscopic gastroenterostomy (LGE); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pyloric Stenosis; Gastric Outlet Obstruction
• Other Study ID Numbers: 202204110RIPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is not a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes