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A Comparison of Eleview Versus Hetastarch as Injectate for EMR

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ClinicalTrials.gov Identifier: NCT03350217
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas K. Rex, Indiana University

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.


Condition or disease Intervention/treatment Phase
Procedural Bleeding Delayed Bleeding Post-Polypectomy Syndrome Post Procedural Complication Drug: Eleview Drug: Hetastarch Phase 4

Detailed Description:

Injectate randomization:

Study patients will be randomly assigned to the Eleview or the Hetastarch treatment group in a 1:1 ratio. Randomization will occur at the site using envelopes provided by the Investigator. The envelope's contents will specify the treatment assignment for each patient and opened by the research team (PI will be blinded). The investigators will monitor the safety and effectiveness data. The appropriate solutions will be injected into the submucosal space beneath the lesion(s) to be excised before the lesion(s) is/are removed. Subjects in both groups will receive the appropriate volume of injectate deemed necessary by the PI for the individual patient.

Sample size and Statistical Analysis At least 200 patients will be enrolled. 100 of these patients will be randomized to Eleview injectate and 100 will be given the standard of care, Hetastarch injectate only. Efficacy and safety of Eleview injectate has only been reviewed in one previous study. Therefore, the planned sample size was not calculated using a statistical power analysis, but was regarded as sufficient to repeat the objectives of the COSMO study (2017) and satisfy the exploratory purposes of the present study.

Study personnel will carry out a simple randomization using a commonly used online generator. Randomization assignments will then be sealed until day of procedure until patient eligibility has been confirmed. The Principal Investigator will remain blinded and will perform all data analysis after completion of the study.

Data will be summarized and compared using classic descriptive statistics, i.e. mean, standard deviation, coefficient of variation (%), minimum, median and maximum values for quantitative variables, and frequencies for qualitative variables.

The Sydney Resection Quotient will be compared between treatment groups using a Wilcoxon Rank-Sum test. The proportion of subjects with en bloc resection of all endoscopically visible lesions will also be compared between treatment groups using a Fisher's exact test. A nominal alpha level of 0.05 will be used for both the comparisons.

No formal comparison will be performed for the secondary endpoints.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Comparative, Effectiveness and Safety Study of Eleview vs. Hetastarch in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger Than 11mm
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : January 7, 2019
Actual Study Completion Date : January 7, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Hextend

Arm Intervention/treatment
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.
Drug: 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.

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.
Drug: 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.
Other Name: Hespan




Primary Outcome Measures :
  1. To evaluate the effectiveness of Eleview in comparison to Hetastarch for use in EMR. [ Time Frame: Through study completion, 8 months. ]
    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.


Secondary Outcome Measures :
  1. Secondary objectives: Effectiveness will be evaluated by the Sydney Resection Quotient (SRQ) [ Time Frame: Through study completion, 8 months. ]
    Effectiveness will be evaluated by the Sydney Resection Quotient (SRQ), which is defined as the size of the polyp divided by the number of pieces resected.

  2. Secondary endpoints: Effectiveness of Eleview compared to Hetastarch in terms of: [ Time Frame: Through study completion, 8 months. ]
    Injected volume needed for initial lesion lift

  3. Secondary endpoints: Effectiveness of Eleview compared to Hetastarch in terms of: [ Time Frame: Through study completion, 8 months. ]
    Injected volume needed for complete removal of lesion

  4. Secondary endpoints: Effectiveness of Eleview compared to Hetastarch in terms of: [ Time Frame: Through study completion, 8 months. ]
    Number of re-injections (number of times the injection device is passed down the scope) needed during resection

  5. Secondary endpoints: Effectiveness of Eleview compared to Hetastarch in terms of: [ Time Frame: Through study completion, 8 months. ]
    Number of pieces resected using snares

  6. Secondary endpoints: Effectiveness of Eleview compared to Hetastarch in terms of: [ Time Frame: Through study completion, 8 months. ]
    Ease of use for polyp removal and fluid behavior rated on a 4-point scale

  7. Secondary endpoints: Effectiveness of Eleview compared to Hetastarch in terms of: [ Time Frame: Through study completion, 8 months. ]
    Time (in minutes) to remove the lesion completely (measured from the first injection to final excision of the lesion)

  8. Secondary endpoints: Effectiveness of Eleview compared to Hetastarch in terms of: [ Time Frame: Through study completion, 8 months. ]
    Need for additional treatments relating to the polyp resection such as avulsion, coagulation or ablation.

  9. Secondary endpoints: Effectiveness of Eleview compared to Hetastarch in terms of: [ Time Frame: Through study completion, 8 months. ]
    Pathological reports for negative lateral and/or deep margins (lateral margins only accurately assessed in en bloc resections)

  10. Secondary endpoints: Effectiveness of Eleview compared to Hetastarch in terms of: [ Time Frame: Through study completion, 8 months. ]
    Presence and number of deep resections containing muscularis propria.

  11. Secondary endpoints: Effectiveness of Eleview compared to Hetastarch in terms of: [ Time Frame: Through study completion, 8 months. ]
    En-bloc resections histologically examined for free-margins.

  12. Number of en bloc resections [ Time Frame: Through study completion, 8 months. ]
    Evaluate the number of en bloc resections per each arm


Other Outcome Measures:
  1. Safety outcomes as assessed by complications during or after the procedures including: [ Time Frame: Through study completion, 8 months. ]

    Intra-procedural bleeding (bleeding requiring therapeutic intervention during the EMR).

    Early (<24h) and delayed (≥24h post EMR) post-procedural bleeding (bleeding post procedure that necessitates transfusion or endoscopic hemostasis because of hematemesis or a decrease of Hgb concentration of more than 2 g/dL after EMR).

    Perforation Post-Polypectomy Syndrome Hospital admissions for any clinically relevant complications post-procedure.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350217


Locations
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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Douglas Rex Indiana University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Douglas K. Rex, Endoscopy Chief, Indiana University
ClinicalTrials.gov Identifier: NCT03350217     History of Changes
Other Study ID Numbers: 1706751368
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Hydroxyethyl Starch Derivatives
Pharmaceutical Solutions
Plasma Substitutes
Blood Substitutes