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

NCT ID: NCT05564143

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-07-01

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.

Conditions

Malignant Gastric Outlet Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

EUS-guided gastroenterostomy (EUS-GE)

Intervention Type: PROCEDURE

Treatment

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.

Group Type: ACTIVE_COMPARATOR

Laparoscopic gastroenterostomy (LGE)

Intervention Type: PROCEDURE

Treatment

Interventions

EUS-guided gastroenterostomy (EUS-GE)

Treatment

Intervention Type: PROCEDURE

Laparoscopic gastroenterostomy (LGE)

Treatment

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yu-Ting Kuo, MD, MSc

Role: CONTACT

sfstruck@gmail.com

+886-223123456 ext. 265587

Other Identifiers

202204110RIPA

Identifier Type: -

Identifier Source: org_study_id