Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03823690 |
| Other study ID # |
CRE-2018.335 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2020 |
| Est. completion date |
May 30, 2022 |
Study information
| Verified date |
August 2023 |
| 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 (SEMS) 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 SEMS is limited by several problems. In uncovered
SEMS, the long-term patency is reduced by tumor ingrowth leading to subsequent re-stenosis.
In covered SEMS, 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 stents and partially or
fully covered stents 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. 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. We have previously published a novel method of creating EUS-GJ with the use
of a double balloon occluder (EPASS). The device provides a stable condition for performance
of EUS-GJ and improves the safety of the procedure. However, there is limited data on how
EPASS compares to endoscopic stenting. The aim of the current study is thus to compare EPASS
and DS under a randomized setting.
Description:
In recent years, SEMSs 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 pyloro-duodenal SEMS 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 gastrojeunostomies. However, the long-term patency of uncovered SEMS 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 at good risk for surgery with prolonged
life expectancy whilst insertion of pyloro-duodenal SEMS is preferred in patients that are
associated with high-risk for surgery and short life expectancy.
In lieu of the above reasons, it would be the ideal situation if a gastrojejunostomy could be
created endoscopically without surgery. The procedure could potentially avoid the risk of
morbidities and mortalities associated with surgery whilst enjoying the superior patency
associated with a gastrojejunostomy. However, a number of hurdles need to be overcome for
safe creation of an anastomosis endoscopically. Firstly, the collapsed bowel (duodenum or
jejunum) needs to be easily identified from the stomach. Secondly, a reliable method of
creating an anastomosis needs to be available. Lastly, a device for maintaining the
anastomosis between two non-adherent organs is required.
The use of EUS as a platform to create a gastrojejunostomy endoscopically may theoretically
tackle all of the above hurdles. The device could be used in the stomach to visualize the
adjacent duodenum or jejunum for anastomosis. A 19-gauge needle could be used to puncture the
adjacent bowel for passage of a guide-wire to connect the two non-adherent organs.
Thereafter, a SEMS could be placed between the two organs for creation and maintenance of the
anastomosis.
Initial results of EUS-guided gastrojejunostomies from two studies have become available.
Khashab et al reported EUS-GJ in 10 patients. Technical success was achieved in 9 patients
(90%). Clinical success with resumption of solid oral intake was achieved in all 9 patients
(100%), who underwent successful EUS-GE. 8 patients were able to tolerate almost a normal
diet and/or full diet, and 1 patient tolerated a soft diet. There were no procedure-related
adverse events. Mean procedure time was 96 minutes (range 45-152 minutes), and mean length of
hospital stay was 2.2 days. In another multicenter study, 26 patients received EUS-GJ.
Technical success was achieved in 24 patients (92 %). Clinical success was achieved in 22
patients (85 %). Of the 4 patients in whom clinical success was not achieved, 2 had
persistent nausea and vomiting despite a patent EUS-GJ and required enteral feeding for
nutrition, 1 died before the initiation of an oral diet, and 1 underwent surgery for
suspected perforation. Adverse events, including peritonitis, bleeding, and surgery, occurred
in 3 patients (11.5 %). In both of these studies, the AXIOS stent was used for creation of
the anastomosis (Boston Scientific, Natick, MA, USA).
However, a common technical problem exists in both of these 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. Our group has overcome this problem with a novel device - the double balloon
occluder. The device comprises of two balloons that could occlude a segment of bowel. Saline
could then be injected in to the occluded segment resulting in distension of the bowel and
making it possible to be targeted by EUS from the stomach.
Our group has published the results of using the double balloon occluder 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. The
mean post-GOOSS score was significantly higher than the pre-GOOSS score (0.6±0.75 vs
2.94±0.23, p<0.001). None of the patients with successful placement of the stent suffered
from adverse events or recurrent obstruction.
The outcomes of EUS-GJ were recently compared with that of conventional procedures for
management of malignant GOO. In a retrospective study, EUS-GJ was compared with DS. 30
patients received EUS-GJ and 60 patients DS. The technical success rates were similar between
the two groups (96.7% vs. 86.7%, P=0.07). Clinical success was also similar between the two
groups (70.0% vs. 86.7%, P=0.08). The re-intervention rate was significantly higher in the ES
group (43.3% vs. 3.4%, P<0.001), whilst adverse events were comparable (13.3% vs 18.3%, P =
0.549). On multivariate analysis, DS was independently associated with need for
re-intervention (OR 25.7, p=0.004). In another study, EUS-GJ (25 patients) was compared with
laparoscopic gastrojejunostomy (29 patients) 20. Technical success was comparable (88% vs
100%, P = 0.11). Clinical success was similar (84% vs 90%, P = 0.11). Average post-procedure
length of stay was 9.4 days in the EUS-GJ group and 8.9 days in the Lap-GJ group (P = 0.75).
Adverse events were significantly more the lap-GJ group (41% vs 12%, P = 0.03).
Thus, based on the above results, EUS-GJ may be associated with improved outcomes as compared
with conventional procedures for management of malignant GOO. Hence, the aim of the current
study is to compare the efficacies of EPASS versus uncovered pyloro-duodenal stents (DS) in
unresectable malignant gastric outlet obstruction in a randomized setting.
