Polyps of ColonNCT06180798
Cold Snare Endoscopic Mucosal Resection (C-EMR) Versus Hot Snare Endoscopic Mucosal Resection (H-EMR) for Large Colorectal Polyps (10-20 mm)
A study testing cold snare endoscopic mucosal resection (C-EMR) and Hot snare endoscopic mucosal resection (H-EMR) in people with Polyps of Colon and Polyps, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
OBJECTIVES The aim of the study is to compare the efficacy of cold snare EMR versus hot snare EMR for non-pedunculated polyps 10-20mm in size with respect to complete resection rates and adverse events. DESIGN : A Randomised interventional study. Sample size: 330 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Polyps of Colon, Polyps, Polyp Intestine
- What is being tested?
- cold snare endoscopic mucosal resection (C-EMR) and Hot snare endoscopic mucosal resection (H-EMR)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteIndia
- Study dates
- 10 Jan 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult above 18 years
- polyp size greater than 5-10mm.
Who cannot join
- Inflammatory bowel disease
- Familial Polyposis Syndromes
- Patient who is unable to understand study protocol or not consenting
- Severe coagulopathy (INR Greater than 1.5 platelets)
- Receiving antiplatelets withing 5 days of procedure
- If antiplatelets stopped for 5 days-they were restarted on next day after procedure.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Krithi Krishna Koduri
Hyderabad, Telanagana, 500082
Nitin Jagtap, MD
About this study
Official title: Cold Snare Endoscopic Mucosal Resection (C-EMR) Versus Hot Snare Endoscopic Mucosal Resection (H-EMR) for Large Colorectal Polyps (10-20 mm) - A Randomised Control Trail.
OBJECTIVES The aim of the study is to compare the efficacy of cold snare EMR versus hot snare EMR for non-pedunculated polyps 10-20mm in size with respect to complete resection rates and adverse events.
DESIGN : A Randomised interventional study. Sample size: 330
Read the detailed description
- This procedure will be performed by Endoscopists having above 3 years of experience you will be in the left lateral position under propofol sedation.
- In Both groups (a mixture of saline and blue dye will be injected beneath the surface layer,and then a snare(is a ring shaped device used to cut polyp after surrounding it- like a rubber band ) will be used to remove tissue without using heat in Cold Endoscopic mucosal resection group and using electrosurgical unit (to control bleeding and to rapidly dissect soft tissue in surgery) by EndoCut Q mode (ensures safe and effective removal of large lesions in particular large polyps) in Hot Endoscopic mucosal resection group.
- After polypectomy (the surgical removal of a polyp) the area is inspected for residual polyp (presence of any type of tissue) using NBI (Narrow band imaging) and if present, will be CUT OFF.
- A Standard snare ( snare is a ring shaped device used to cut polyp after surrounding it- like a rubber band) is used to cut the polyps
- Conditions
- Polyps of Colon, Polyps, Polyp Intestine
- Being tested
- cold snare endoscopic mucosal resection (C-EMR), Hot snare endoscopic mucosal resection (H-EMR)
- Medical subject headings
- Colonic Polyps, Polyps, Intestinal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold snare endoscopic mucosal resection (C-EMR)Procedure or surgery
All procedures will be performed by experienced endoscopists (>3 years of experience/>1000 polypectomies) with the patient in the left lateral position under propofol sedation.
The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used .
submucosal injection of saline mixed with methylene blue will be used (no epinephrine) followed by resection using snare without using electrocautery in C-EMR group.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.
Bleeding will be assessed for 2 mins to decide upon requirement of immediate hemostatic methods in the form of clipping or electrocoagulation.
Hot snare endoscopic mucosal resection (H-EMR)Procedure or surgery
All procedures will be performed by experienced endoscopists (>3 years of experience/>1000 polypectomies) with the patient in the left lateral position under propofol sedation.
The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.submucosal injection of saline mixed with methylene blue will be used.Using ERBE electrosurgical unit - EndoCut Q mode (effect interval duration) and forced coagulation mode in H-EMR group.
After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.
| Study group | Role | What they receive |
|---|---|---|
| cold snare endoscopic mucosal resection (C-EMR) | Active comparator | All procedures will be performed by experienced endoscopists (>3 years of experience/>1000 polypectomies) with the patient in the left lateral position under propofol sedation.submucosal injection of saline mixed with methylene blue will be used (no epinephrine) followed by resection using snare without using electrocautery in C-EMR group.The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps. Receives: Procedure: cold snare endoscopic mucosal resection (C-EMR) |
| Hot snare endoscopic mucosal resection (H-EMR) | Sham comparator | All procedures will be performed by experienced endoscopists (>3 years of experience/>1000 polypectomies) with the patient in the left lateral position under propofol sedation.Using ERBE electrosurgical unit - EndoCut Q mode (effect interval duration) and forced coagulation mode in H-EMR group.The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps. Receives: Procedure: Hot snare endoscopic mucosal resection (H-EMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the complete resection rate
Primary outcome will be tested with chi-square test or Fisher's exact test. The level of significance has been set at 5%. To quantify the magnitude of the difference the relative risk and odds ratio will be calculated with 95% confidence interval.
Measured: 1 YEAR
Secondary outcomes (1)
Secondary outcomes include procedure time, cost and adverse events.
Univariate and multivariate analysis will be done to determine which are the factors associated with clinical success and clinical recurrence. Kaplan-Meier survival analysis will be done for appearance clinical recurrence.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start10 Jan 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyps of ColonStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center randomized controlled study with two parallel groups with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krithi Krishna Koduri, MD, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180798
- Sponsor's protocol ID
- C-EMR VS H-EMR
- Status last verified
- Jan 2024
- First submitted
- 21 Oct 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Snare Endoscopic Mucosal Resection (C-EMR) Versus Hot Snare Endoscopic Mucosal Resection (H-EMR) for Large Colorectal Polyps (10-20 mm) - A Randomised Control Trail.
- ClinicalTrials.gov ID
- NCT06180798
- Acronym / sponsor ID
- C-EMR VS H-EMR
- Conditions
- Polyps of Colon, Polyps, Polyp Intestine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES The aim of the study is to compare the efficacy of cold snare EMR versus hot snare EMR for non-pedunculated polyps 10-20mm in size with respect to complete resection rates and adverse events.
DESIGN : A Randomised interventional study. Sample size: 330
Detailed description
- This procedure will be performed by Endoscopists having above 3 years of experience you will be in the left lateral position under propofol sedation.
- In Both groups (a mixture of saline and blue dye will be injected beneath the surface layer,and then a snare(is a ring shaped device used to cut polyp after surrounding it- like a rubber band ) will be used to remove tissue without using heat in Cold Endoscopic mucosal resection group and using electrosurgical unit (to control bleeding and to rapidly dissect soft tissue in surgery) by EndoCut Q mode (ensures safe and effective removal of large lesions in particular large polyps) in Hot Endoscopic mucosal resection group.
- After polypectomy (the surgical removal of a polyp) the area is inspected for residual polyp (presence of any type of tissue) using NBI (Narrow band imaging) and if present, will be CUT OFF.
- A Standard snare ( snare is a ring shaped device used to cut polyp after surrounding it- like a rubber band) is used to cut the polyps
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a single center randomized controlled study with two parallel groups with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| cold snare endoscopic mucosal resection (C-EMR) | Active comparator | Procedure: cold snare endoscopic mucosal resection (C-EMR)All procedures will be performed by experienced endoscopists (>3 years of experience/>1000 polypectomies) with the patient in the left lateral position under propofol sedation.submucosal injection of saline mixed with methylene blue will be used (no epinephrine) followed by resection using snare without using electrocautery in C-EMR group.The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps. |
| Hot snare endoscopic mucosal resection (H-EMR) | Sham comparator | Procedure: Hot snare endoscopic mucosal resection (H-EMR)All procedures will be performed by experienced endoscopists (>3 years of experience/>1000 polypectomies) with the patient in the left lateral position under propofol sedation.Using ERBE electrosurgical unit - EndoCut Q mode (effect interval duration) and forced coagulation mode in H-EMR group.The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult above 18 years
- polyp size greater than 5-10mm.
Key exclusion criteria (6 listed)
- Inflammatory bowel disease
- Familial Polyposis Syndromes
- Patient who is unable to understand study protocol or not consenting
- Severe coagulopathy (INR Greater than 1.5 platelets)
- Receiving antiplatelets withing 5 days of procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cold snare endoscopic mucosal resection (C-EMR)All procedures will be performed by experienced endoscopists (>3 years of experience/>1000 polypectomies) with the patient in the left lateral position under propofol sedation. The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used . submucosal injection of saline mixed with methylene blue will be used (no epinephrine) followed by resection using snare without using electrocautery in C-EMR group.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps. Bleeding will be assessed for 2 mins to decide upon requirement of immediate hemostatic methods in the form of clipping or electrocoagulation. | Procedure or surgery | cold snare endoscopic mucosal resection (C-EMR) |
| Hot snare endoscopic mucosal resection (H-EMR)All procedures will be performed by experienced endoscopists (>3 years of experience/>1000 polypectomies) with the patient in the left lateral position under propofol sedation. The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.submucosal injection of saline mixed with methylene blue will be used.Using ERBE electrosurgical unit - EndoCut Q mode (effect interval duration) and forced coagulation mode in H-EMR group. After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps. | Procedure or surgery | Hot snare endoscopic mucosal resection (H-EMR) |
Primary outcome
Assess the complete resection rate
Time frame: 1 YEAR
Primary outcome will be tested with chi-square test or Fisher's exact test. The level of significance has been set at 5%. To quantify the magnitude of the difference the relative risk and odds ratio will be calculated with 95% confidence interval.
1 secondary outcome
Secondary outcomes include procedure time, cost and adverse events.
Time frame: 1 YEAR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krithi Krishna Koduri, MD principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold snare endoscopic mucosal resection (C-EMR) and Hot snare endoscopic mucosal resection (H-EMR) in people with Polyps of Colon and Polyps, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krithi Krishna Koduri, MD (9870083545 ext. 91, drkrithivk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the complete resection rate (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.