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Endoscopic Direct-PEG Placement in Patients Unable to Undergo Pull-PEG Procedure

NCT04151030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-09-01

No results posted yet for this 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.

Conditions

  • Head and Neck Neoplasm
  • Gastrostomy
  • Esophageal Stenosis and Obstruction

Interventions

PROCEDURE

PEG placement

Push PEG placement

Sponsors & Collaborators

  • Kansas City Veteran Affairs Medical Center

    lead FED

Principal Investigators

  • Divyanshoo Kohli, MD · Kansas City VA Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-28
Primary Completion
2021-07-01
Completion
2021-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04151030 on ClinicalTrials.gov