A Comparison of Eleview Versus Hetastarch as Injectate for EMR
Condition: Procedural Bleeding; Delayed Bleeding; Post-Polypectomy Syndrome; Post Procedural Complication
MeSH terms: Hemorrhage
Intervention: Eleview; Hetastarch
Intervention description: 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.; 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.
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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.
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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:

          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.