A randomised, double blinded trial of Succinylated Gelatin versus normal saline for submucosal injection for colonic endoscopic mucosal resection (EMR)
In patients undergoing colonic EMR (endoscopic mucosal resection) for large sessile polyps, succinylated gelatin may be a superior submucosal injectant compared with normal saline.
Dr Alan Moss and Dr Michael Bourke
160 participants
Apr 28, 2009
Interventional
Conditions
Summary
En bloc resection (ie. in a single piece) is the goal for removing large sessile colonic polyps. Currently this is limited to 20mm in size with the standard submucosal injection solution (ie. normal saline). Succinylated Gelatin is a colloid, that has been proven to be safe and superior to normal saline for EMR in a porcine model. With Human Research approval, this study is to assess the efficacy and safety of succinylated gelatin for sessile colonic polyps sized 20mm or greated.
Eligibility
Inclusion Criteria1
- Sessile polyp sized 20mm or larger intended for EMR
Exclusion Criteria8
- Personal history of allergy to gelatin, Gelofusine or Haemaccel
- Pregnancy: currently pregnant or attempting to become pregnant
- Lactation: currently breastfeeding
- Taken clopidogrel within 7 days
- Taken warfarin within 5 days
- Had full therapeutic dose unfractionated heparin within 6 hours
- Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
- Known clotting disorder
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Interventions
Colonic submucosal injection of succinylated gelatin for EMR (volume of injection is at discretion of endoscopist and will vary with size of the lesion for resection)
Locations(1)
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ACTRN12609000939291