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Gastrojejunostomy Techniques for Gastric Outlet Obstruction

Q: In what quantity has this research recruited participants?

<p>Affirmative. The clinicaltrials.gov registry clarifies that this medical trial is open to participants, having been first published on September 15th and amended the following day. Currently, 24 individuals from a single site are being sought for recruitment into this research study.</p>

Q: Is there still an opportunity for participants to join this research project?

<p>That is correct. According to clinicaltrials.gov, the trial first posted on September 15th 2022 and was recently updated on September 16th 2022 is currently searching for 24 participants from a single location.</p>

N/A

Recruiting

Led By Ji Young Bang, MD MPH

Research Sponsored by Orlando Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Presence of gastric outlet obstruction on any imaging or endoscopy from known or suspected malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial compares the outcomes of two treatments for a cancer that is blocking the stomach from emptying into the small intestine.

Who is the study for?

This trial is for adults over 18 with gastric outlet obstruction due to cancer, who can only consume liquids. It's not for those under 18, pregnant women, or patients on anticoagulants that can't be stopped.Check my eligibility

What is being tested?

The study compares two procedures in patients with malignant gastric outlet obstruction: EUS-guided gastrojejunostomy (a less invasive endoscopic procedure) and traditional surgical gastrojejunostomy.See study design

What are the potential side effects?

Possible side effects include pain at the procedure site, infection risk, bleeding complications especially if previous anticoagulant use isn't properly managed, and potential anesthesia-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have a blockage in my stomach due to cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring endoscopic or surgical intervention or supplemental nutrition or procedure-related adverse events.

Secondary outcome measures

Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).

Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).

Length of survival

+12 more

Trial Design

2Treatment groups

Active Control

Group I: EUS-guided gastrojejunostomyActive Control1 Intervention

EUS-guided gastrojejunostomy is performed using a lumen-apposing metal stent

Group II: Surgical gastrojejunostomyActive Control1 Intervention

A surgical gastrojejunostomy will be created via laparoscopic or open technique, as clinically appropriate.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush UniversityOTHER

40 Previous Clinical Trials

383,918 Total Patients Enrolled

Orlando Health, Inc.Lead Sponsor

28 Previous Clinical Trials

12,643 Total Patients Enrolled

West Virginia UniversityOTHER

176 Previous Clinical Trials

60,114 Total Patients Enrolled

Media Library

EUS-guided gastrojejunostomy Clinical Trial Eligibility Overview. Trial Name: NCT05548114 — N/A

Gastric Outlet Obstruction Research Study Groups: EUS-guided gastrojejunostomy, Surgical gastrojejunostomy

Gastric Outlet Obstruction Clinical Trial 2023: EUS-guided gastrojejunostomy Highlights & Side Effects. Trial Name: NCT05548114 — N/A

EUS-guided gastrojejunostomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05548114 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what quantity has this research recruited participants?

"Affirmative. The clinicaltrials.gov registry clarifies that this medical trial is open to participants, having been first published on September 15th and amended the following day. Currently, 24 individuals from a single site are being sought for recruitment into this research study."

Answered by AI

Is there still an opportunity for participants to join this research project?

"That is correct. According to clinicaltrials.gov, the trial first posted on September 15th 2022 and was recently updated on September 16th 2022 is currently searching for 24 participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

2022. "Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05548114.