Phase 4
N=160
A Comparison of Eleview Versus Hetastarch as Injectate for EMR
Procedural Bleeding · Delayed Bleeding · Post-Polypectomy Syndrome · Post Procedural Complication
Bottom Line
View on ClinicalTrials.gov: NCT03350217 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Sydney Resection Quotient (SRQ) — 9.3; 8.1; 12.3; 11.1 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Eleview (Drug); Hetastarch (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sydney Resection Quotient (SRQ) |
9.3; 8.1; 12.3; 11.1 | — |
| SECONDARY Injected Volume Needed for Initial Lesion Lift |
10.4; 11.6; 7.1; 8.7 | — |
| SECONDARY Injected Volume Needed for Complete Removal of Lesion |
14.8; 20.6; 7.8; 10.7 | — |
| SECONDARY Number of Re-injections Needed During Resection |
0.61; 1.01; 0.1; 0.3 | — |
| SECONDARY Number of En Bloc Resections |
18; 14; 2; 2 | — |
| SECONDARY Number of Pieces Resected Using Snares |
4.5; 5.5; 7; 8.2 | — |
| SECONDARY Mound Concentration Diameter |
64; 54; 41; 41; 9; 7 | — |
| SECONDARY Mound Concentration Height |
67; 58; 37; 38; 10; 6 | — |
| SECONDARY Mound Duration |
60; 58; 41; 39; 11; 5 | — |
| SECONDARY Ease of Injection |
52; 46; 58; 52; 3; 3 | — |
| SECONDARY Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation. |
37; 36; 72; 55; 9; 7 | — |
| SECONDARY Time Required to Remove the Lesion |
14.8; 16.02; 5.9; 7.1 | — |
| SECONDARY Safety Outcomes as Assessed by Complications During or After the Procedure |
18; 14; 1; 1; 0; 1 | — |
Summary
EMR is a technique used for the removal of flat or sessile neoplasms confined to the superficial layers of the GI tract using a snare. Injection-assisted EMR is commonly used during resections of larger flat lesions as it provides submucosal lift of polyps, adenomas, other gastrointestinal mucosal lesions or early-stage cancers prior to EMR. This has been found to minimize mechanical or electrocautery damage to the deep layers of the gastrointestinal tract wall as the injectate provides a "safety cushion" as such between the area to be removed and healthy mucosal tissue.
Several solutions are used today for injecting lesions including saline, hyaluronic acid, and hydroxyethyl starch (Hetastarch). Saline solution has been found to dissipate within minutes, which may result in a lower quality lesion lift. Hyaluronic acid provides a longer lift, but is expensive and is not readily available in the U.S.
A new injectate known as Eleview has been developed for use in gastrointestinal endoscopic procedures and recently approved by the FDA. This injectate boasts a cushion of excellent height and duration through the use of an oil-in-water emulsion. However, the initial cost of this material is quite high ($80 per 10 ml).
Hetastarch, which is the current injectate used by Dr Rex, is a safe and considerably inexpensive solution that provides prolonged submucosal elevation and lowers procedure times. Our study will aim to compare Eleview to Hetastarch in the hopes of finding the ideal submucosal injectate.
This trial will focus on polyps of size ≥11 mm removed by snare EMR technique. Patients with lesions deemed not suitable for EMR due to features suggestive of sub-mucosal invasion will not be included.
Eligibility Criteria
Inclusion Criteria
- Sex and age: men and women > 18 years old
- Subjects referred for EMR of polyps of size ≥11 mm
- ASA score 1, 2 or 3.
- Contraception: Women of childbearing potential must have a negative pregnancy test (one is provided as the standard of care) or sign a waiver. Post-menopausal women must have been in that status for at least 1 year (per standard of care).
- Subject is willing and able to participate in the study procedures and to understand and sign the informed consent
Exclusion Criteria
- Age: Subjects is under 18 years old
- Consent: Vulnerable subjects including those who are unable to consent
- Pregnancy: Pregnant or breastfeeding women
- ASA score 1.5).
- Subject with any other current serious medical conditions that would increase the risks associated with taking part in the study.
- Patients must be advised to stop anticoagulation medications prior to the procedure per local practice guidelines and should re-start as clinically indicated after the procedure.
Data sourced from ClinicalTrials.gov (NCT03350217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.