Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03223480 |
| Other study ID # |
CRE2017.277 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
August 24, 2018 |
| Est. completion date |
August 14, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
In recent years, DSEMSs have provided an attractive alternative to surgery for palliation of
malignant gastric outlet obstruction. Several studies have assessed the clinical and
technical success rates of DSEMS for malignant gastroduodenal obstruction. Technical success
rates of 90% to 100% and clinical success of 80% to 95% was achieved.The procedure was
associated with quicker recovery and reduced morbidities as compared to surgical
gastrojejunostomies. However, the long-term patency of uncovered DSEMS is limited by the risk
of tumor ingrowth that would lead to subsequent re-stenosis of the stents requiring
re-intervention. Thus to palliate malignant gastric outlet obstruction, surgical
gastrojejunostomy is preferred in patients that are fit for surgery with prolonged life
expectancy whilst insertion of DSEMS is preferred in patients that are associated with
high-risk for surgery and short life expectancy.
Recently, EUS-guided gastrojejunostomies have become possible. In the early description, a
common technical problem exists in the series. The target duodenum or jejunum needed for
creation of a GJ is collapsed and it is difficult to identify the target organ by EUS from
the stomach. Furthermore, the insertion of the stent for creation of the anastomosis may be
difficult with a collapsed bowel and this may result in catastrophic outcomes. To overcome
this difficulty, our group has published the results of using the double balloon occluder
that allows distension of the duodenum in conjunction with the AXIOS stent for creation of a
GJ in 20 patients (Endoscopic ultrasonography-guided double-balloon-occluded
gastrojejunostomy bypass - EPASS). The technical success rate was 90% (18/20). The median
intubation time from the double-balloon tube intubation to stent placement was 25.5 min
(range 10-39 min). Post-treatment gastric outlet obstruction scoring system (GOOSS) score
improved in all 18 cases in which EPASS was successfully performed.
Thus, based on the above results, EUS-GJ may be associated with improved outcomes as compared
with conventional procedures for management of malignant GOO. The aim of the current study is
to compare the efficacies of EPASS in a prospective multicenter setting versus a historical
cohort of uncovered DSEMS for patients suffering from unresectable malignant GOO.
