A Comparison of Eleview Versus Hetastarch as Injectate for EMR

NCT03350217 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1706751368
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Procedural Bleeding; Delayed Bleeding; Post-Polypectomy Syndrome; Post Procedural Complication

Outcome Measures

Primary Outcomes (1)

• Sydney Resection Quotient (SRQ)

  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.

  During the large polyp removal

Secondary Outcomes (12)

• Injected Volume Needed for Initial Lesion Lift

  During initial injection portion of large polyp removal

• Injected Volume Needed for Complete Removal of Lesion

  During the large polyp removal

• Number of Re-injections Needed During Resection

  During the large polyp removal

• Number of En Bloc Resections

  During the large polyp removal

• Number of Pieces Resected Using Snares

  During the large polyp removal

Study Arms (2)

Eleview

ACTIVE COMPARATOR

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.

Drug: Eleview

Hetastarch

ACTIVE COMPARATOR

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.

Drug: Hetastarch

Interventions

Eleview DRUG

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.

Eleview

Hetastarch DRUG

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.

Also known as: Hespan

Hetastarch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age: Subjects is under 18 years old
• Consent: Vulnerable subjects including those who are unable to consent
• Pregnancy: Pregnant or breastfeeding women
• ASA score \<3
• Physical findings: Abnormal physical findings that may interfere with the study objectives
• Study participation: Subjects currently participating in another clinical study or previously enrolled in another clinical study in the last 30 days
• 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
• Previous partial resection or attempted resection of the lesion
• Allergy: Proven or potential allergic reaction to study products or history of anaphylaxis to drugs

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (4)

• Fasoulas K, Lazaraki G, Chatzimavroudis G, Paroutoglou G, Katsinelos T, Dimou E, Geros C, Zavos C, Kountouras J, Katsinelos P. Endoscopic mucosal resection of giant laterally spreading tumors with submucosal injection of hydroxyethyl starch: comparative study with normal saline solution. Surg Laparosc Endosc Percutan Tech. 2012 Jun;22(3):272-8. doi: 10.1097/SLE.0b013e318251553c.

  PMID: 22678327 BACKGROUND

• ASGE Technology Committee; Liu J, Petersen BT, Tierney WM, Chuttani R, Disario JA, Coffie JM, Mishkin DS, Shah RJ, Somogyi L, Song LM. Endoscopic banding devices. Gastrointest Endosc. 2008 Aug;68(2):217-21. doi: 10.1016/j.gie.2008.03.1121. No abstract available.

  PMID: 18656592 BACKGROUND

• ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.

  PMID: 26077453 BACKGROUND

• Rex 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 DERIVED

MeSH Terms

Interventions

SIC-8000; Hydroxyethyl Starch Derivatives

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Limitations and Caveats

limitations include single-center, single-endoscopist design which could limit the generalizability.

Results Point of Contact

• Title: Clinical Research Specialist
• Organization: Indiana University

rlahr@iu.edu

317-948-0724

Study Officials

• Douglas Rex

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Investigator is blinded to the randomization process but can be unblinded after the product has been dispensed if the patient has a medical issue that requires it.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endoscopy Chief

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: November 22, 2017
• Study Start: October 9, 2017
• Primary Completion: January 7, 2019
• Study Completion: January 7, 2019
• Last Updated: December 17, 2019
• Results First Posted: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)