Primary objective:to investigate and compare the effect of EUS-GE and SGJ on patients* short- and long-term ability to eat* (time to oral intake, and reinterventions for persistent or recurrent symptoms of GOO within 6 months of follow-up,…
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the ability to eat, measured with co-primary
endpoints: 1) time to oral intake, and 2) persistent or recurrent gastric
outlet obstruction (GOO) symptoms requiring endoscopic or surgical
reintervention.
Secondary outcome
- Technical success;
- Clinical success;
- Gastroenterostomy dysfunction;
- Reintervention;
- Time to reintervention due to recurrent symptoms;
- Adverse events; .
- Quality of life;
- Time to start chemotherapy;
- Length of hospital stay;
- Readmission rate;
- Weight is defined as patients* weight in kilograms;
- Survival;
- Costs.
Background summary
Malignant gastric outlet obstruction (GOO) is a common problem in patients with
advanced primary or metastatic malignancy located at the distal stomach and
(peri)pancreatic region. With a reasonable life expectancy, surgical
gastrojejunostomy (SGJ) is indicated to bypass this obstruction and palliate
obstructive symptoms. Despite high technical success rates and a durable
effect, SGJ is an invasive treatment that is associated with significant
short-term morbidity, such as gastroparesis, resulting in an ongoing inability
to eat and prolonged hospital stay. Endoscopic ultrasonography-guided
gastroenterostomy (EUS-GE) using a Lumen Apposing Metal Stent (LAMS) is the
newest technique in the palliative treatment of malignant GOO. EUS-GE creates a
bypass in a minimally invasive manner, with the potential of providing both
fast and lasting relief of obstructive symptoms. Despite promising preliminary
data, current literature is limited to small and retrospective series. A
prospective and comparative study is warranted, to compare short and long term
efficacy of EUS-GE with SGJ.
Study objective
Primary objective:
to investigate and compare the effect of EUS-GE and SGJ on patients* short- and
long-term ability to eat* (time to oral intake, and reinterventions for
persistent or recurrent symptoms of GOO within 6 months of follow-up,
respectively)
Secondary objectives/questions:
- What is the technical success rate of EUS-GE vs SGJ?
- What is the clinical success rate of EUS-GE vs SGJ?
- What is the rate of gastroenterostomy dysfunction of EUS-GE vs SGJ?
- What is the reintervention rate of EUS-GE vs SGJ?
- What is the time to reintervention in case of recurrent symptoms after EUS-GE
vs SGJ?
- What is the adverse events rate of EUS-GE vs SGJ?
- What is the effect of EUS-GE vs SGJ on the quality of life?
- What is the time to start chemotherapy (if applicable) after EUS-GE vs SGJ?
- What is the length of hospital stay of EUS-GE vs SGJ?
- What is the rate of readmissions after EUS-GE vs SGJ?
- What is the patients* weight after EUS-GE vs SGJ (baseline vs one month after
treatment)?
- What is the overall survival time after EUS-GE vs SGJ?
- What are the costs involved in EUS-GE vs SGJ?
Study design
National multicenter study
Randomized controlled trial
Intervention
After randomization, one group will receive the standard treatment (surgical
gastrojejunostomy; SGJ), the other group will receive the experimental
treatment (endoscopic ultrasonography-guided gastroenterostomy; EUS-GE)
Study burden and risks
The burden and risks of EUS-GE are expected to be lower than those of the
standard treatment (SGJ). Participation in this therapeutic study offers
patients with malignant GOO the opportunity to undergo EUS-GE, an
investigational and minimally invasive treatment, instead of surgery. No
additional visits or physical examinations are required for this study, unless
medically indicated. The burden of follow-up within this study is limited and
mainly concerns time that is spent to fill in the diary, short quality-of-life
questionnaires and receive four short follow-up phone calls. Though the
short-term results of EUS-GE are promising and seem to be beneficial, the
long-term patency of EUS-GE has yet to be established and compared with the
current standard treatment (SGJ). This can only adequately be achieved by
comparing the efficacy of EUS-GE versus SGJ in these patients, in a randomized
and prospective study with solid follow-up.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Adult patients with symptomatic malignant gastric outlet obstruction,
presenting with nausea, vomiting and/or inability to eat
- Gastric Outlet Obstruction Scoring System Score of 0 (no oral intake) or 1
(liquids only)
- Obstruction due to irresectable or metastatic malignancy without curative
treatment options
- Radiologically or endoscopically confirmed gastric outlet obstruction
- Location of obstruction extending from the distal 1/3 of the stomach (antrum)
to the distal duodenum (third part)
- Both treatments (SGJ and EUS-GE) are technically and clinically feasible
- Written informed consent
Exclusion criteria
- Radiological or clinical suspicion of other strictures or obstructions along
the gastrointestinal tract (distal of Treitz), with small intestine intestinal
dilation/ileus. Note: patients with diffuse dilatation of the intestines should
not be excluded;
- Cancer extending into the body of the stomach or around the ligament of
Treitz;
- Duodenal tube feeding is not tolerated by the patient, despite adequate
position of the tube;
- Altered anatomy after previous gastric, periampullary or duodenal surgery;
- Previous SGJ as palliative treatment for the same condition;
- Inability to undergo surgery or upper endoscopy due to severe comorbidities;
- WHO performance score of 4 (in bed 100% of time);
- Uncorrectable coagulopathy, defined by INR>1.5 or platelets < 50 x 10^9/L;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77548.041.21 |
| Other | NL9592 |
| OMON | NL-OMON25505 |