Trial · Interventional

CompletedPhase 4Results postedRegistry data

A Comparison of Eleview Versus Hetastarch as Injectate for EMR

NCTNCT03350217Other id1706751368

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names Methylene blue, does not test it. It appears in the description.

Overview

Status: Completed
Phase: Phase 4
Enrollment: 160 participants (actual)
Sponsor: Indiana University · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: 9 Oct 2017
Primary completion: 7 Jan 2019
Completion: 7 Jan 2019
First posted: 22 Nov 2017
Last update posted: 17 Dec 2019
Conditions: Procedural Bleeding · Delayed Bleeding · Post-Polypectomy Syndrome · Post Procedural Complication

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2017201820192020

Ph 4
A Comparison of Eleview Versus Hetastarch as Injectate for EMR
NCT03350217
9 Oct 2017 to 7 Jan 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

EleviewDrug
HetastarchDrug

Arms2

Active comparator
Eleview
This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Active comparator
Hetastarch
This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.

Primary outcomes1

Outcomes the sponsor listed as primary.

Sydney Resection Quotient (SRQ)
Time frame · During the large polyp removal
Registry description
Comparison of the Sydney Resection Quotient between EMRs done using Eleview vs EMRs done using Hetastartch as the injection fluid. The Sydney Resection Quotient (SRQ) is the size of the polyp divided by the number of pieces in which the polyp was resected. A larger SRQ is better than a smaller SRQ.

Secondary outcomes(12)

Injected Volume Needed for Initial Lesion Lift
Time frame · During initial injection portion of large polyp removal
Registry description
Comparison of the volume of injection fluid needed for initial lesion lift of Eleview vs Hetastarch.
Injected Volume Needed for Complete Removal of Lesion
Time frame · During the large polyp removal
Registry description
Comparison of the volume of injection fluid needed for complete removal of lesion between Eleview and Hetastarch
Number of Re-injections Needed During Resection
Time frame · During the large polyp removal
Registry description
Comparison of the number of re-injections needed during the large polyp removal. Number of re-injections is the number of times the injection device is passed down the scope to inject the polyp after initial injection during the large polyp resection.
Number of En Bloc Resections
Time frame · During the large polyp removal
Registry description
Comparison of the number of polyps that were able to be removed in one piece during the resection between polyps injected with Eleview and polyps injected with Hetastarch
Number of Pieces Resected Using Snares
Time frame · During the large polyp removal
Registry description
Comparison of the number of pieces removed using snare between polyps injected with Eleview compared with polyps injected with Hetastarch.
Mound Concentration Diameter
Time frame · During the large polyp removal
Registry description
Comparison fluid behavior and ease of use between Eleview and Hetastarch rated on a 3-point scale (Excellent, Sufficient, or Inadequate). The more the fluid spread out laterally after being injected, the worse the rating would be. The more the fluid stayed concentrated around the polyp after injection, the better the rating would be.
Mound Concentration Height
Time frame · During the large polyp removal
Registry description
Comparison of how well the injection fluid lifted the polyp during the large polyp removal between Eleview and Hetastarch rated by the following scale: Excellent, Sufficient, Inadequate. The more the polyp was able to be lifted vertically, the better the rating would be.
Mound Duration
Time frame · During the large polyp removal
Registry description
Comparison of how long the injection fluid was able to keep the polyp lifted during the large polyp removal between Eleview and Hetastarch. This was rating using the following scale: Excellent, Sufficient, or Inadequate. The longer the injection fluid stayed concentrated and kept the polyp lifted, the better rating it received while rapid dissipation of the fluid would receive a worse rating.
Ease of Injection
Time frame · During the large polyp removal
Registry description
Comparison of how easily the fluid was able to be injected. This was rated by the endoscopy technician assisting in the large polyp removal. It was rated on the following scale: Very Easy, Easy, Difficult, Very Difficult.
Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation.
Time frame · During the large polyp removal
Registry description
Need for additional treatments relating to the polyp resection such as avulsion, coagulation or ablation. These treatments can be done in addition to endoscopic mucosal resection (EMR) in order to remove polyp tissue/treat the defect.
Time Required to Remove the Lesion
Time frame · During the large polyp removal
Registry description
Time (in minutes) to remove the lesion completely (measured from the first injection to final excision of the lesion)
Safety Outcomes as Assessed by Complications During or After the Procedure
Time frame · during large polyp removal through 30 days post procedure
Registry description
To evaluate the safety of Eleview for EMR procedures in relation to adverse events and occurrence of complications during and after the EMR procedure in comparison to Hetastarch injectate.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· During the large polyp removal

Sydney Resection Quotient (SRQ)

Group	Value (Ratio)	Spread
Eleview	9.3	6.2
Hetastarch	8.1	4.9

Secondary and other outcome results(7)

Secondary outcomeMean· During initial injection portion of large polyp removal

Injected Volume Needed for Initial Lesion Lift

Group	Value (milliliters)	Spread
Eleview	10.4	5.4
Hetastarch	11.6	7

Secondary outcomeMean· During the large polyp removal

Injected Volume Needed for Complete Removal of Lesion

Group	Value (milliliters)	Spread
Eleview	14.8	13.1
Hetastarch	20.6	20.9

Secondary outcomeMean· During the large polyp removal

Number of Re-injections Needed During Resection

Group	Value (reinjections)	Spread
Eleview	0.61	1.3
Hetastarch	1.01	1.6

Secondary outcomeNumber· During the large polyp removal

Number of En Bloc Resections

Group	Value (Polyps)
Eleview	18
Hetastarch	14

Secondary outcomeMean· During the large polyp removal

Number of Pieces Resected Using Snares

Group	Value (polyp pieces resected)	Spread
Eleview	4.5	5
Hetastarch	5.5	5.3

Secondary outcomeNumber· During the large polyp removal

Mound Concentration Diameter

Group	Value (Polyps)
Eleview	64
Hetastarch	54

Secondary outcomeNumber· During the large polyp removal

Mound Concentration Height

Group	Value (Polyps)
Eleview	67
Hetastarch	58

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
EleviewThis arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters. Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.	0 / 77	0 / 77	16 / 77
HetastarchThis arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters. Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.	0 / 81	0 / 81	15 / 81

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedRex DK, Broadley HM, Garcia JR, Lahr RE, MacPhail ME, McWhinney CD, Searight MP, Sullivan AW, Mahajan N, Eckert GJ, Vemulapalli KC. SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial. Gastrointest Endosc. 2019 Nov;90(5):807-812. doi: 10.1016/j.gie.2019.06.040. Epub 2019 Jul 6. PMID 31288028

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Sex and age: men and women \> 18 years old 2. Subjects referred for EMR of polyps of size ≥11 mm 3. ASA score 1, 2 or 3. 4. 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). 5. Subject is willing and able to participate in the study procedures and to understand and sign the informed consent Exclusion Criteria: 1. Age: Subjects is under 18 years old 2. Consent: Vulnerable subjects including those who are unable to consent 3. Pregnancy: Pregnant or breastfeeding women 4. ASA score \<3 5. Physical findings: Abnormal physical findings that may interfere with the study objectives 6. Study participation: Subjects currently participating in another clinical study or previously enrolled in another clinical study in the last 30 days 7. Excluded lesions: * Lesions less than 11 mm in largest dimension * Lesions involving the muscularis propria (T2 lesions) * Ulcerated depressed lesions (Paris type III) or pathology proven invasive carcinoma * Proven malignant disease locally advanced or with metastasis * Active inflammatory bowel disease lesion, e.g ulcerative colitis, Crohn's disease * Endoscopic appearance of invasive malignancy 8. Previous partial resection or attempted resection of the lesion 9. Allergy: Proven or potential allergic reaction to study products or history of anaphylaxis to drugs 10. Severe liver disease. 11. Known or suspected gastrointestinal obstruction or perforation, active diverticulitis, toxic megacolon, 12. Inflammatory bowel disease e.g ulcerative colitis or Crohn's disease 13. Hemostasis disorders (eg Von Willebrand disease, factor V Leiden thrombophilia or haemophilia), known clotting disorder (INR\>1.5). 14. Subject with any other current serious medical conditions that would increase the risks associated with taking part in the study. 15. 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.

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