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NCT04151030 · ClinicalTrials.gov registry record · NA
Endoscopic Direct-PEG Placement in Patients Unable to Undergo Pull-PEG Procedure
A NA study, sponsored by Kansas City Veteran Affairs Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT04151030 is a NA study that has completed, run by Kansas City Veteran Affairs Medical Center. The registered enrollment target is 45 participants.
The verdict
NCT04151030, a NA study, has completed, sponsored by Kansas City Veteran Affairs Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study Summary
Placement of a feeding tube through a gastrostomy can be performed endoscopically or radiologically. While percutaneous endoscopic gastrostomy (PEG) tube placement is most frequently performed using a "pull" technique, this method may not feasible in patients with malignant, or tight benign, esophageal stenosis. Further, the "pull" technique may drag tumor cells with the feeding tube and lead to implantation metastasis at the gastrostomy site. A clinical practice update by the American Gastroenterological Association has recommended that the pull-through PEG placement method should be avoided in all patients with oropharyngeal or esophageal cancer. It also recommends that the introducer/Push PEG method should be favored instead of the pull PEG. In such situations, an introducer-style, "Direct" gastrostomy tube can be placed endoscopically or radiologically. However, the published data comparing outcomes and safety of endoscopic "Direct" PEG (D-PEG) and interventional radiological PEG (IR-PEG) are very sparse. The D-PEG is performed under endoscopic visualization of the gastric wall which facilitates greater control and allows safe selection of gastrostomy site. Further, the presence of an endoscope enables transillumination to confirm the absence of intervening abdominal viscera between the abdominal wall and the anterior wall of the stomach. These advantages are lacking with the IR-PEG. We hypothesize that D-PEG is safer than IR-PEG. In this single center, non-randomized study, patients unable to undergo a conventional per-oral "Pull" PEG and needing a D-PEG will be prospectively enrolled. For the comparison arm, historical IR-PEG procedures at our center will be assessed. The technical success and rates of adverse events will be compared between the two arms. Approval from the Institutional review board has been obtained. Based on our experience, we estimate a sample size of 40 participants in each arm and anticipate completion of this pilot study by June 2021.
Interventions
- PROCEDURE PEG placement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-06-28 |
| Est. Completion | 2021-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04151030
The ClinicalTrials.gov registry entry for NCT04151030 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kansas City Veteran Affairs Medical Center, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PEG placement is the first listed.
NCT04151030 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04151030 about?
NCT04151030 is a clinical study titled "Endoscopic Direct-PEG Placement in Patients Unable to Undergo Pull-PEG Procedure". Placement of a feeding tube through a gastrostomy can be performed endoscopically or radiologically. While percutaneous endoscopic gastrostomy (PEG) tube placement is most frequently performed using a "pull" technique, this method may not feasible in patients with malignant, or tight benign, esophag...
What is the current status of trial NCT04151030?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2019-06-28. Estimated completion is 2021-07-01.
What interventions are being tested in trial NCT04151030?
The interventions under investigation include: PEG placement (PROCEDURE).
Who is sponsoring clinical trial NCT04151030?
This trial is sponsored by Kansas City Veteran Affairs Medical Center, which has 2 total clinical trials registered on ClinicalTrials.gov.
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