Clinical trial · Interventional
Endoscopic Direct-PEG Placement in Patients Unable to Undergo Pull-PEG Procedure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Stenosis and Obstruction | — | UNRESOLVED | — |
| Gastrostomy | — | UNRESOLVED | — |
| Head and Neck Neoplasm | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endoscopic-PEG
- description
- 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
- interventionNames
- Procedure: PEG placement
- type
- ACTIVE_COMPARATOR
- label
- IR-PEG
- description
- Patients who underwent PEG placement by interventional radiology (IR-PEG).
- interventionNames
- Procedure: PEG placement
Primary outcomes (1)
- measure
- Technical success of endoscopic vs radiographic Push-PEG placement in patients who are not candidates for a Pull-PEG placement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Successful placement of Pull PEG * Ascites, pregnancy
References
Publications (1)
- DERIVEDKohli 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