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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000939291

Enrollment

Registered

2009-11-03

Start date

2009-04-28

Completion date

2009-11-17

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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)

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Sessile polyp sized 20mm or larger intended for EMR

Exclusion criteria

- 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

Outcome results