NCT04151030: PEG

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

Completed NA Last updated 1 September 2021

What this trial tests

NA trial testing PEG placement in Head and Neck Neoplasm in 45 participants. Completed in 1 July 2021.

Timeline

28 June 2019

Primary endpoint
1 July 2021

1 July 2021

Quick facts

Lead sponsor	Kansas City Veteran Affairs Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	28 June 2019
Primary completion	1 July 2021
Estimated completion	1 July 2021
Sites	1 location across United States

Drugs / interventions tested

• PEG placement

Conditions studied

• Head and Neck Neoplasm — all drugs for Head and Neck Neoplasm →
• Gastrostomy — all drugs for Gastrostomy →
• Esophageal Stenosis and Obstruction — all drugs for Esophageal Stenosis and Obstruction →

Sponsor

Kansas City Veteran Affairs Medical Center

Who can join

18 and older, any sex, with Head and Neck Neoplasm or Gastrostomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Direct Percutaneous Endoscopic Gastrostomy Versus Radiological Gastrostomy in Patients Unable to Undergo Transoral Endoscopic Pull Gastrostomy.
   Kohli DR, Smith C, Chaudhry O, Desai M, et al · · 2023 · cited 5× · PMID 35708794 · DOI 10.1007/s10620-022-07569-7