Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000939291
Ethics application status
Approved
Date submitted
28/10/2009
Date registered
3/11/2009
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, double blinded trial of Succinylated Gelatin versus normal saline for submucosal injection for colonic endoscopic mucosal resection (EMR)
Scientific title
In patients undergoing colonic EMR (endoscopic mucosal resection) for large sessile polyps, succinylated gelatin may be a superior submucosal injectant compared with normal saline.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sessile polyps of the colon 252069 0
Condition category
Condition code
Oral and Gastrointestinal 252271 252271 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 241463 0
Treatment: Drugs
Comparator / control treatment
Colonic submucosal injection of normal saline for EMR (volume of injection is at discretion of endoscopist and will vary with size of the lesion for resection)
Control group
Active

Outcomes
Primary outcome [1] 253143 0
Ratio of size of lesion (in mm) to number of snare resection pieces (calculated by dividing lesion size by the number of snare resection pieces)
Timepoint [1] 253143 0
Immediately post-procedure
Secondary outcome [1] 262039 0
Percentage of lesions resected en bloc
Timepoint [1] 262039 0
Immediately post-procedure
Secondary outcome [2] 262040 0
Number of adverse events (including bleeding requiring intervention, perforation, allergy, hospitalisation)
Timepoint [2] 262040 0
Immediately post procedure and 2 weeks post procedure
Secondary outcome [3] 262041 0
Number of submucosal injections performed,
Timepoint [3] 262041 0
Immediately post-procedure
Secondary outcome [4] 262042 0
Total volume of injectant used
Timepoint [4] 262042 0
Immediately post-procedure
Secondary outcome [5] 262043 0
Duration of EMR procedure
Timepoint [5] 262043 0
Immediately post-procedure

Eligibility
Key inclusion criteria
Sessile polyp sized 20mm or larger intended for EMR
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
PLEASE NOTE that an interim analysis will be conducted after 80 patients have been enrolled.
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/04/2009
Actual
28/04/2009
Date of last participant enrolment
Anticipated
Actual
17/11/2009
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
160
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243933 0
Self funded/Unfunded
Name [1] 243933 0
Country [1] 243933 0
Primary sponsor type
Individual
Name
Dr Alan Moss and Dr Michael Bourke
Address
Endoscopy Unit
Westmead Hospital
Corner Hawkesbury and Darcy Roads
Westmead
NSW 2145
Country
Australia
Secondary sponsor category [1] 251290 0
None
Name [1] 251290 0
Address [1] 251290 0
Country [1] 251290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244047 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 244047 0
Ethics committee country [1] 244047 0
Australia
Date submitted for ethics approval [1] 244047 0
Approval date [1] 244047 0
16/02/2009
Ethics approval number [1] 244047 0

Summary
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.
Trial website
Trial related presentations / publications
A randomized, double-blind trial of succinylated gelatin submucosal injection for endoscopic resection of large sessile polyps of the colon.
Moss A, Bourke MJ, Metz AJ.
American Journal of Gastroenterology 2010 Nov; 105(11):2375-82.
Public notes

Contacts
Principal investigator
Name 30426 0
Address 30426 0
Country 30426 0
Phone 30426 0
Fax 30426 0
Email 30426 0
Contact person for public queries
Name 13673 0
Dr Alan Moss
Address 13673 0
Endoscopy Unit
Westmead Hospital
Corner Hawkesbury and Darcy Roads
Westmead
NSW 2145
Country 13673 0
Australia
Phone 13673 0
(61) 2 9845 5555
Fax 13673 0
(61) 2 9845 5637
Email 13673 0
dralanmoss@hotmail.com
Contact person for scientific queries
Name 4601 0
Dr Alan Moss
Address 4601 0
Endoscopy Unit
Westmead Hospital
Corner Hawkesbury and Darcy Roads
Westmead
NSW 2145
Country 4601 0
Australia
Phone 4601 0
(61) 2 9845 5555
Fax 4601 0
(61) 2 9845 5637
Email 4601 0
dralanmoss@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.