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

NCT05564143 | Unknown

• 1 other identifier: 202204110RIPA
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Technical success rate

  1 day

• Clinical success rate

  1 week

• Re-intervention rate

  6 months

• Duration of gastroenterostomy patency

  6 months

• Adverse events rates

  6 months

Study Arms (2)

EUS-guided gastroenterostomy (EUS-GE)

ACTIVE COMPARATOR

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)

Laparoscopic gastroenterostomy (LGE)

ACTIVE COMPARATOR

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)

Interventions

EUS-guided gastroenterostomy (EUS-GE) PROCEDURE

Treatment

EUS-guided gastroenterostomy (EUS-GE)

Laparoscopic gastroenterostomy (LGE) PROCEDURE

Treatment

Laparoscopic gastroenterostomy (LGE)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients ≥ 20 years old
• Confirmed unresectable distal gastric or duodenal or pancreatico-biliary malignancies
• Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1
• Performance status ECOG ≤3

You may not qualify if:

• Unable to give informed consent
• Prior duodenal metallic stent placement
• Severe comorbidities precluding the endoscopic procedure or operation
• Life expectancy of less than 1 month
• History of gastric surgery
• Linitus plastic
• Multiple-level bowel obstruction confirmed on radiographic studies such as small bowel series or abdominal computed tomography
• Coagulation disorders
• Pregnancy

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Central Study Contacts

Yu-Ting Kuo, MD, MSc

CONTACT

+886-223123456; sfstruck@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: October 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share