EUS - Guided Balloon-occluded Gastrojejunostomy Bypass

NCT03223480 | Completed Phase 2 DMC

• 1 other identifier: CRE2017.277
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical gastrojejunostomy is the conventional treatment for palliating patients suffering from of inoperable malignant gastric outlet obstruction (GOO). Although, the procedure is associated with a high success and low re-intervention rates, there is a risk of morbidities (10% - 16%) and mortalities (7%). The placement of a pyloro-duodenal self-expandable metallic stent (DSEMS) is an alternative to surgery for the palliating these patients. As compared to surgery, the procedure is associated with shorter hospital stay, reduced morbidities and cost. However, the clinical efficacy of DSEMS is limited by several problems. In uncovered DSEMS, the long-term patency is reduced by tumor ingrowth leading to subsequent re-stenosis. In covered DSEMS, stent migration occurs at a frequency of 14 - 25% and it is a major obstacle to stent patency. As a result, randomized trials comparing uncovered DSEMS and partially or fully covered DSEMS in patients with malignant GOO have reported comparable stent patency between the two types of stents. Recently, the creation of a gastrojejunostomy under EUS (EUS-GJ) guidance using lumen-apposing stents has been described 12-16. The procedure was associated with a technical success rate of around 90% and clinical success of 85% to 100%. The procedure holds the potential to create a gastrojejunostomy without surgery. Furthermore, there is a low risk of tumor ingrowth and stent migration, thus improving the stent patency and reducing the need of re-intervention. However, there is limited data on how EPASS compares to endoscopic stenting. The aim of the current study is thus to compare prospective data on EPASS versus a historical group that received DSEMS.

Conditions

Gastric Outlet Obstruction

Outcome Measures

Primary Outcomes (1)

• 6 month re-intervention rate

  percentage of patients requiring additional endoscopic intervention due to stent dysfunction

  6 months

Secondary Outcomes (7)

• technical success

  1 day

• clinical success

  7 days

• adverse events rate

  30 days

• mortality

  30 days

• Post stenting gastric outlet obstruction scores

  7 days

Study Arms (1)

EUS-guided gastrojejunostomy

EXPERIMENTAL

The procedures would be performed under conscious sedation or monitored anesthesia by a therapeutic gastroscope. The endoscope would be used to reach the site of obstruction. The stricture would be cannulated with a 0.025" or 0.035" guide-wire. The double balloon occluder would then be inserted on guidewire beyond the duodenal-jejunal flexure and the two balloons of the occluder would be inflated. A segment of duodenum/jejunum would then be occluded and saline would be injected. A linear echoendoscope would then be inserted into the stomach to guide insertion of the gastrojejunostomy stent.

Device: EUS-guided gastrojejunstomy

Interventions

EUS-guided gastrojejunstomy DEVICE

As listed in the arms description

EUS-guided gastrojejunostomy

Eligibility Criteria

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

You may qualify if:

• Consecutive patients ≥ 18 years old
• Biopsy and/or cytology confirmed unresectable distal gastric or duodenal or pancreatico-biliary malignancies
• Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1 (appendix 1) 19 Performance status ECOG ≤3 (appendix 2)

You may not qualify if:

• Prior metallic stent placement
• Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder)
• 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

• Chinese University of Hong Kong: lead
• Tokyo Medical University: collaborator

Study Sites (1)

Department of Surgery, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Gastric Outlet Obstruction

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All patients recruited will receive EUS-guided gastrojejunostomy using the double balloon occluder

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: August 24, 2018
• Primary Completion: August 14, 2021
• Study Completion: August 14, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

HK (1)