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

NCT04151030 | Completed

• 1 other identifier: 01049
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Technical success of endoscopic vs radiographic Push-PEG placement in patients who are not candidates for a Pull-PEG placement

  Successful placement of PEG

  30 days

Secondary Outcomes (2)

• Incidence of adverse events between endoscopic push PEG placement and IR guided push PEG placement

  30 days

• Procedure duration between endoscopic push PEG placement and IR guided push PEG placement

  At the time of procedure

Study Arms (2)

Endoscopic-PEG

EXPERIMENTAL

The patients who are unable to undergo an endoscopic pull PEG placement, will undergo an Endoscopic "introducer style" Direct-PEG procedure at the time of the index endoscopy

Procedure: PEG placement

IR-PEG

ACTIVE COMPARATOR

Patients who underwent PEG placement by interventional radiology (IR-PEG).

Procedure: PEG placement

Interventions

PEG placement PROCEDURE

Push PEG placement

Endoscopic-PEG; IR-PEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Placement of PEG tube for dysphagia
• Inability of participant to undergo conventional Pull PEG (for any reason)
• Attempt at placement of a Push PEG
• Age \> 18 years and able to consent

You may not qualify if:

• Successful placement of Pull PEG
• Ascites, pregnancy

Sponsors & Collaborators

• Kansas City Veteran Affairs Medical Center: lead

Study Sites (1)

Kansas City VA medical center

Kansas City, Missouri, 64128, United States

Location

Related Publications (1)

• Kohli DR, Smith C, Chaudhry O, Desai M, DePaolis D, Sharma P. Direct Percutaneous Endoscopic Gastrostomy Versus Radiological Gastrostomy in Patients Unable to Undergo Transoral Endoscopic Pull Gastrostomy. Dig Dis Sci. 2023 Mar;68(3):852-859. doi: 10.1007/s10620-022-07569-7. Epub 2022 Jun 16.

  PMID: 35708794 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Esophageal Stenosis; Bites and Stings

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Divyanshoo Kohli, MD

  Kansas City VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, gastroenterology

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: June 28, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)