Gastric Outlet ObstructionNCT07161856
Novel Balloon-Assisted vs Direct Technique in EUS-Guided Gastroenterostomy
A study testing a novel balloon-assisted EUS-GE and direct EUS-GE in people with Gastric Outlet Obstruction, run by Changhai Hospital.
Trial summary
Gastric outlet obstruction (GOO) refers to mechanical blockage at the pylorus or duodenum, most commonly caused by unresectable malignancies of the stomach, duodenum, or pancreas. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Outlet Obstruction
- What is being tested?
- a novel balloon-assisted EUS-GE and direct EUS-GE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranges from 18 to 80 years old
- GOO patients caused by all reasons (including benign diseases such as ulcers or malignant tumors)
- Not suitable for or cannot tolerate surgical operations and endoscopic intestinal stent implantation
- There are no absolute contraindications for EUS-GE
- Signed informed consents
Who cannot join
- Pregnant and lactating women
- Unable or refused to provide informed consents
- Patients with cognitive impairment, aphasia, mental disorders, or other conditions that may affect the patient's cooperation
- Patients with endoscopic contraindications, anesthesia contraindications, digestive tract perforation or abdominal cavity infection
- The tumor invades the duodenum or the upper segment of the jejunum Individuals whom the investigator deems unsuitable for participation
About this study
Official title: Novel Balloon-Assisted vs Direct Technique in EUS-Guided Gastroenterostomy: A Prospective Multicenter RCT
Gastric outlet obstruction (GOO) refers to mechanical blockage at the pylorus or duodenum, most commonly caused by unresectable malignancies of the stomach, duodenum, or pancreas. At the time of diagnosis, the majority of lesions are no longer amenable to curative resection, and median survival ranges from only 11.3 to 21.3 weeks. Throughout the disease course, patients develop nausea, vomiting, and severe malnutrition, which markedly impair quality of life. Current strategies to relieve obstruction include endoscopic stent placement and surgical gastrojejunostomy; however, each is associated with distinct drawbacks, such as stent occlusion, prolonged operative times, and high complication rates.
Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a minimally invasive technique in which a gastric-jejunal anastomosis is created under real-time EUS guidance, bypassing the obstructed segment and establishing a gastrojejunal shortcut. Compared with conventional surgery or endoscopic luminal stenting, EUS-GE offers reduced procedural trauma and lower recurrence rates, providing GOO patients with an additional, less-invasive therapeutic option.
Read more
Three main EUS-GE approaches have been described: the direct method, the balloon-assisted method, and the double-balloon-assisted method. The direct method requires large volumes of water instillation, posing hemodynamic risks in patients with cardiovascular or cerebrovascular disease. The double-balloon technique relies on expensive, specialized devices that have not yet been widely adopted. The conventional balloon-assisted method demands needle puncture of a partially inflated balloon, which compromises stability and can displace the target jejunum away from the gastric wall. All three techniques are technically demanding, limiting their broad clinical dissemination.
The investigators therefore designed and previously reported a dedicated single-balloon-assisted device specifically for EUS-GE. This novel system aims to shorten procedure time, reduce intraprocedural water volume, and enhance procedural safety. The present prospective, multicenter, randomized controlled trial was undertaken to validate the clinical efficacy and safety of this new single-balloon-assisted technique compared with the conventional direct water-injection method.
Read the detailed description
This multicenter, single-blind, RCT is designed to enroll 272 patients across five high-volume tertiary referral centers in China. The study is planned to commence in July 2025 and continue until the final patient completed 12 months of follow-up or passed away. The primary outcome is the operation duration. Secondary outcomes are technical success rate, clinical success rate, intraoperative water injection volume, quality of life assessment, length of hospital stay, and incidence of adverse events (AEs).
- Conditions
- Gastric Outlet Obstruction
- Being tested
- a novel balloon-assisted EUS-GE, direct EUS-GE
- 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.
a novel balloon-assisted EUS-GEProcedure or surgery
The patients will receive EUS-NBAGE under general anesthesia with endotracheal intubation. Under direct visualization with a gastroscope, contrast medium is injected to determine the location and length of the stricture. A guidewire is then placed through the stricture into the jejunum, approximately 15 cm distal to the anal side of the stricture. A double-balloon device is inserted over the guidewire. The anal-side balloon is inflated with about 40 mL of air, and under fluoroscopy, the balloon is confirmed to be well inflated. A mixture of contrast medium and methylene blue in a 1:1 dilution is injected into the proximal small intestine through the water injection channel at the proximal end of the catheter. A linear echoendoscope is inserted into the mid-body of the stomach on the greater curvature side to scan the distended small intestine loop. After identifying the distended small intestine loop, a HOT-AXIOS 1.5×1.0cm LAMS is placed under direct visualization.
direct EUS-GEProcedure or surgery
The patients will receive EUS-DGE under general anesthesia with endotracheal intubation. Under direct visualization with a gastroscope, a guidewire and/or nasobiliary catheter is passed through the stricture into the jejunum. A mixture of contrast medium and methylene blue is injected to distend the target intestinal loop. An echoendoscope is introduced into the stomach to select the optimal puncture site.
A 19G or 22G puncture needle is used to puncture the gastric and jejunal walls. Aspiration of fluid confirms the needle tip is in the jejunum, after which the channel is dilated over the guidewire. Using the delivery system of an electrocautery-enhanced fully covered lumen-apposing metal stent (LAMS), the stent is deployed to complete the gastrojejunostomy.
| Study group | Role | What they receive |
|---|---|---|
| direct EUS-GE | Active comparator | The patients will receive EUS-DGE under general anesthesia with endotracheal intubation. Under direct visualization with a gastroscope, a guidewire and/or nasobiliary catheter is passed through the stricture into the jejunum. A mixture of contrast medium and methylene blue is injected to distend the target intestinal loop. An echoendoscope is introduced into the stomach to select the optimal puncture site.
A 19G or 22G puncture needle is used to puncture the gastric and jejunal walls. Aspiration of fluid confirms the needle tip is in the jejunum, after which the channel is dilated over the guidewire. Using the delivery system of an electrocautery-enhanced fully covered lumen-apposing metal stent (LAMS), the stent is deployed to complete the gastrojejunostomy. Receives: Procedure: direct EUS-GE |
| a novel balloon-assisted EUS-GE | Experimental | The patients will receive EUS-NBAGE under general anesthesia with endotracheal intubation. Under direct visualization with a gastroscope, contrast medium is injected to determine the location and length of the stricture. A guidewire is then placed through the stricture into the jejunum, approximately 15 cm distal to the anal side of the stricture. A double-balloon device is inserted over the guidewire. The anal-side balloon is inflated with about 40 mL of air, and under fluoroscopy, the balloon is confirmed to be well inflated. A mixture of contrast medium and methylene blue in a 1:1 dilution is injected into the proximal small intestine through the water injection channel at the proximal end of the catheter. A linear echoendoscope is inserted into the mid-body of the stomach on the greater curvature side to scan the distended small intestine loop. After identifying the distended small intestine loop, a HOT-AXIOS 1.5×1.0cm LAMS is placed under direct visualization. Receives: Procedure: a novel balloon-assisted EUS-GE |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation duration
the duration from the moment the surgical instrument enters the body and begins operation until the completion of the gastrojejunostomy and placement of the intraluminal stent
Measured: Perioperative
Secondary outcomes (1)
technical success
successfully pass through the narrow intestinal segment and implant the stent, that is, the LAMS stent fully expands and is confirmed through a combination of endoscopy, ultrasound and fluorescence microscopy
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Outlet ObstructionStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161856
- Sponsor's protocol ID
- CHEC2025-284
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary and secondary outcome measures could be shared without sharing patient privacy. Interested parties can contact by email
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Balloon-Assisted vs Direct Technique in EUS-Guided Gastroenterostomy: A Prospective Multicenter RCT
- ClinicalTrials.gov ID
- NCT07161856
- Acronym / sponsor ID
- CHEC2025-284
- Conditions
- Gastric Outlet Obstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric outlet obstruction (GOO) refers to mechanical blockage at the pylorus or duodenum, most commonly caused by unresectable malignancies of the stomach, duodenum, or pancreas. At the time of diagnosis, the majority of lesions are no longer amenable to curative resection, and median survival ranges from only 11.3 to 21.3 weeks. Throughout the disease course, patients develop nausea, vomiting, and severe malnutrition, which markedly impair quality of life. Current strategies to relieve obstruction include endoscopic stent placement and surgical gastrojejunostomy; however, each is associated with distinct drawbacks, such as stent occlusion, prolonged operative times, and high complication rates.
Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a minimally invasive technique in which a gastric-jejunal anastomosis is created under real-time EUS guidance, bypassing the obstructed segment and establishing a gastrojejunal shortcut. Compared with conventional surgery or endoscopic luminal stenting, EUS-GE offers reduced procedural trauma and lower recurrence rates, providing GOO patients with an additional, less-invasive therapeutic option.
Three main EUS-GE approaches have been described: the direct method, the balloon-assisted method, and the double-balloon-assisted method. The direct method requires large volumes of water instillation, posing hemodynamic risks in patients with cardiovascular or cerebrovascular disease. The double-balloon technique relies on expensive, specialized devices that have not yet been widely adopted. The conventional balloon-assisted method demands needle puncture of a partially inflated balloon, which compromises stability and can displace the target jejunum away from the gastric wall. All three techniques are technically demanding, limiting their broad clinical dissemination.
The investigators therefore designed and previously reported a dedicated single-balloon-assisted device specifically for EUS-GE. This novel system aims to shorten procedure time, reduce intraprocedural water volume, and enhance procedural safety. The present prospective, multicenter, randomized controlled trial was undertaken to validate the clinical efficacy and safety of this new single-balloon-assisted technique compared with the conventional direct water-injection method.
Detailed description
This multicenter, single-blind, RCT is designed to enroll 272 patients across five high-volume tertiary referral centers in China. The study is planned to commence in July 2025 and continue until the final patient completed 12 months of follow-up or passed away. The primary outcome is the operation duration. Secondary outcomes are technical success rate, clinical success rate, intraoperative water injection volume, quality of life assessment, length of hospital stay, and incidence of adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct EUS-GE | Active comparator | Procedure: direct EUS-GEThe patients will receive EUS-DGE under general anesthesia with endotracheal intubation. Under direct visualization with a gastroscope, a guidewire and/or nasobiliary catheter is passed through the stricture into the jejunum. A mixture of contrast medium and methylene blue is injected to distend the target intestinal loop. An echoendoscope is introduced into the stomach to select the optimal puncture site. A 19G or 22G puncture needle is used to puncture the gastric and jejunal walls. Aspiration of fluid confirms the needle tip is in the jejunum, after which the channel is dilated over the guidewire. Using the delivery system of an electrocautery-enhanced fully covered lumen-apposing metal stent (LAMS), the stent is deployed to complete the gastrojejunostomy. |
| a novel balloon-assisted EUS-GE | Experimental | Procedure: a novel balloon-assisted EUS-GEThe patients will receive EUS-NBAGE under general anesthesia with endotracheal intubation. Under direct visualization with a gastroscope, contrast medium is injected to determine the location and length of the stricture. A guidewire is then placed through the stricture into the jejunum, approximately 15 cm distal to the anal side of the stricture. A double-balloon device is inserted over the guidewire. The anal-side balloon is inflated with about 40 mL of air, and under fluoroscopy, the balloon is confirmed to be well inflated. A mixture of contrast medium and methylene blue in a 1:1 dilution is injected into the proximal small intestine through the water injection channel at the proximal end of the catheter. A linear echoendoscope is inserted into the mid-body of the stomach on the greater curvature side to scan the distended small intestine loop. After identifying the distended small intestine loop, a HOT-AXIOS 1.5×1.0cm LAMS is placed under direct visualization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ranges from 18 to 80 years old
- GOO patients caused by all reasons (including benign diseases such as ulcers or malignant tumors)
- Not suitable for or cannot tolerate surgical operations and endoscopic intestinal stent implantation
- There are no absolute contraindications for EUS-GE
- Signed informed consents
Key exclusion criteria (5 listed)
- Pregnant and lactating women
- Unable or refused to provide informed consents
- Patients with cognitive impairment, aphasia, mental disorders, or other conditions that may affect the patient's cooperation
- Patients with endoscopic contraindications, anesthesia contraindications, digestive tract perforation or abdominal cavity infection
- The tumor invades the duodenum or the upper segment of the jejunum Individuals whom the investigator deems unsuitable for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a novel balloon-assisted EUS-GEThe patients will receive EUS-NBAGE under general anesthesia with endotracheal intubation. Under direct visualization with a gastroscope, contrast medium is injected to determine the location and length of the stricture. A guidewire is then placed through the stricture into the jejunum, approximately 15 cm distal to the anal side of the stricture. A double-balloon device is inserted over the guidewire. The anal-side balloon is inflated with about 40 mL of air, and under fluoroscopy, the balloon is confirmed to be well inflated. A mixture of contrast medium and methylene blue in a 1:1 dilution is injected into the proximal small intestine through the water injection channel at the proximal end of the catheter. A linear echoendoscope is inserted into the mid-body of the stomach on the greater curvature side to scan the distended small intestine loop. After identifying the distended small intestine loop, a HOT-AXIOS 1.5×1.0cm LAMS is placed under direct visualization. | Procedure or surgery | a novel balloon-assisted EUS-GE |
| direct EUS-GEThe patients will receive EUS-DGE under general anesthesia with endotracheal intubation. Under direct visualization with a gastroscope, a guidewire and/or nasobiliary catheter is passed through the stricture into the jejunum. A mixture of contrast medium and methylene blue is injected to distend the target intestinal loop. An echoendoscope is introduced into the stomach to select the optimal puncture site. A 19G or 22G puncture needle is used to puncture the gastric and jejunal walls. Aspiration of fluid confirms the needle tip is in the jejunum, after which the channel is dilated over the guidewire. Using the delivery system of an electrocautery-enhanced fully covered lumen-apposing metal stent (LAMS), the stent is deployed to complete the gastrojejunostomy. | Procedure or surgery | direct EUS-GE |
Primary outcome
operation duration
Time frame: Perioperative
the duration from the moment the surgical instrument enters the body and begins operation until the completion of the gastrojejunostomy and placement of the intraluminal stent
1 secondary outcome
technical success
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Yes. Primary and secondary outcome measures could be shared without sharing patient privacy. Interested parties can contact by email
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing a novel balloon-assisted EUS-GE and direct EUS-GE in people with Gastric Outlet Obstruction, run by Changhai Hospital.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
operation duration (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2025.