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Gastric Outlet ObstructionPhase 2/3NCT03223480

EUS - Guided Balloon-occluded Gastrojejunostomy Bypass

A Phase 2/3 study testing EUS-guided gastrojejunstomy in people with Gastric Outlet Obstruction, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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%). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Outlet Obstruction
What is being tested?
EUS-guided gastrojejunstomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteHong Kong
Study dates
24 Aug 2018to 14 Aug 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Department of Surgery, Prince of Wales Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: EUS - Guided Balloon-occluded Gastrojejunostomy Bypass (EPASS) for Unresectable Malignant Gastric Outlet Obstruction.

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.

Read the detailed 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.

Being tested
EUS-guided gastrojejunstomy
Medical subject headings
Gastric Outlet Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EUS-guided gastrojejunstomyDevice

    As listed in the arms description

Study groups in NCT03223480
Study groupRoleWhat they receive
EUS-guided gastrojejunostomyExperimentalThe 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.
Receives: Device: EUS-guided gastrojejunstomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 month re-intervention rate

    percentage of patients requiring additional endoscopic intervention due to stent dysfunction

    Measured: 6 months

Secondary outcomes (7)

  1. technical success

    successful placement of a stent across the site of obstruction, as confirmed by endoscopy or fluoroscopy

    Measured: 1 day

  2. clinical success

    improvement of at least 1 point in the GOOS within 3 days after stent insertion

    Measured: 7 days

  3. adverse events rate

    graded according to the lexicon of endoscopic adverse

    Measured: 30 days

  4. mortality

    Death within 30 day of the procedure

    Measured: 30 days

  5. Post stenting gastric outlet obstruction scores

    Degree of oral intake after stenting

    Measured: 7 days

  6. the duration of stent patency

    How long the stent remains patent

    Measured: 6 months

  7. quality of life assessment scores

    EORTC QLQ-C30

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start24 Aug 2018
  3. Primary completion14 Aug 2021
  4. Study completion14 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All patients recruited will receive EUS-guided gastrojejunostomy using the double balloon occluder
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03223480
Sponsor's protocol ID
CRE2017.277
Status last verified
Nov 2021
First submitted
19 Jul 2017
Last updated
15 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing EUS-guided gastrojejunstomy in people with Gastric Outlet Obstruction, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 month re-intervention rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03223480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.

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