Clinical trial · Interventional
Performance of Endoscopic Submucosal Dissection According to the Sedation Method
- 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)
Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection, the effects of sedation on ESD performance and complications have not been fully evaluated. In the investigators previous retrospective study, en bloc resection and complete resection rates, and procedure time could be improved by sedation with continuous propofol infusion with opioid administration by anesthesiologists. However, there are several limitations to the study including retrospective design. The investigators aimed to evaluate the relationship among sedation methods, satisfaction of endoscopists or patients, clinical outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Gastric Adenoma | Gastric Adenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuous propofol infusion with opioid administration | Procedure | — | UNRESOLVED |
| Intermittent midazolam/propofol injection controlled by endoscopist | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- midazolam/propofol injection
- description
- Intermittent midazolam/propofol injection controlled by endoscopist
- interventionNames
- Procedure: Intermittent midazolam/propofol injection controlled by endoscopist
- type
- ACTIVE_COMPARATOR
- label
- propofol infusion
- description
- Continuous propofol infusion with opioid administration
- interventionNames
- Procedure: Continuous propofol infusion with opioid administration
Primary outcomes (1)
- measure
- Satisfaction of endoscopists
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age, between 20 and 80 2. Early gastric cancer or adenoma, which is indicated by endoscopic submucosal dissection 3. ECOG performance status 0 or 1 4. American Society of Anesthesiologist Physical Status 1, 2, or 3 Exclusion Criteria: 1. Previous subtotal gastrectomy 2. Previous gastrostomy 3. Repeated endoscopic submucosal dissection 4. Three or more synchronous lesions 5. Allergy to midazolam, propofol, fentanyl, or remifentanil 6. Pregnancy or breast milk feeding 7. Active infection 8. Significant cardiopulmonary disease 9. Active hepatitis or severe hepatic dysfunction 10. Severe renal dysfunction 11. Severe bone marrow dysfunction 12. Severe neurologic or psychotic disorder
References
Publications (1)
- DERIVEDPark CH, Shin S, Lee SK, Lee H, Lee YC, Park JC, Yoo YC. Assessing the stability and safety of procedure during endoscopic submucosal dissection according to sedation methods: a randomized trial. PLoS One. 2015 Mar 24;10(3):e0120529. doi: 10.1371/journal.pone.0120529. eCollection 2015. PMID 25803441