Adenoma ColonNCT04418843

Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions

A study testing Standard Endoscopic Mucosal Resection and Cold Snare Endoscopic Mucosal Resection in people with Adenoma Colon and Serrated Polyp, run by Oscar Nogales at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study compares the effectiveness in complete resection (absence of recurrence at 6 months) the two different techniques for performing endoscopic mucosal resection (EMR) of nonpedunculated homogeneous colorectal lesions >20mm Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Adenoma Colon, Serrated Polyp, Serrated Adenoma
What is being tested?: Standard Endoscopic Mucosal Resection and Cold Snare Endoscopic Mucosal Resection
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 229 participants
Where: 1 siteSpain
Study dates: 8 Jun 2020to 31 Mar 2023
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients of age > 18 years undergoing a colonoscopy for any reason of request and who do not meet exclusion criteria.
Nonpedunculated homogeneous colorectal lesions type LST ( Paris 0-IIa morphology) and serrated lesions larger than 20 mm without endoscopic data of malignancy: NICE 1 pattern +/- NICE 2 component ( serrated lesions) or NICE2 pattern/JNET 2A (adenomas) and therefore subsidiaries of RME. Randomization will be performed per patient, not for colorectal lesions
Signature of informed consent of endoscopic exploration

Who cannot join

.No signature of informed consent prior to the study procedure.
Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations (BSG and ESGE guidelines)
Patients with severe thrombopenia/ coagulopathy (Platelets < 50,000/INR > 1.5) not corrected prior to procedure (plasma or platelet transfusion)
Patients not candidates for endoscopic resection of colorectal lesions by comorbidities.
Pregnant.
Patients with inflammatory bowel disease (IBD)

Show all 11Show fewer

Urgent colonoscopy.
Poor preparation (BBPS <2 in the colon segment where the lesion is located)
Laterally spreading tumors (LST) lesions with non-homogeneous morphology including: sessile polyps (0-Is), pedunculated (0-Ip) and LST lesions with depressed or excavated components (Paris 0-IIc or Paris 0-III), LST granular nodular mixed, LST-G with whole nodular type. In case of doubt depressed component (Paris 0-IIc) or histological borderline lesion (JNET2B), will be excluded from the study.
Histological prediction of deep invasive or non-subsidiary to endoscopic mucosal resection lesion as a treatment of choice: NICE 3 pattern by inspection with NBI or Kudo V pattern in traditional/electronic chromoendoscopy or Sano IIIA/IIIB pattern
Endoscopic resection of post-EMR scar level relapses

Trial locations and contacts

1 site in 1 country.

Spain1 site

Óscar Nogales Rincón
Madrid, 28007

Other trials in Spain

About this study

Official title: Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions.Randomized and Multicentric Clinical Trial

Read the detailed description

Colonoscopy is the reference diagnostic test for the study of colon diseases. This procedure also allows the realization of endoscopic therapeutics techniques; thus, endoscopic mucosal resection (EMR) is an effective and safe therapy for the treatment of premalignant and early malignant colorectal lesions of the colon and its use is universal.

Usually, colon lesions larger than 10 mm (or pedunculated of any size) require for resection the use of electrocoagulation current (or hot snare polypectomy) and thus is reflected in the most recent clinical practice guidelines (ESGE guidelines, for example). However, the risk of side adverse effects from the use of electrocoagulation is not insignificant and includes post-polypectomy bleeding, post-polypectomy syndrome, post-polypectomy fever and/or immediate or delayed perforation. This risk of complications is higher depending on the characteristics and size of colorectal lesions resected.

On the other hand, currently in small lesions not pedunculated (< 10 mm), it is recommended to use cold snare polypectomy according to ESGE clinical guidelines, as it has been seen in previous studies that this reduces complication rates without varying the effectiveness in resection.

However, in lesions > 10 mm the previous experience with cold snare resection is less, probably motivated by the possible drawbacks in terms of the possible difficulty of resection of thick tissue with cold snare and a possible increased intra-procedure hemorrhagic risk that can make it difficult to see the scar, with the possibility of leaving residual tissue.

However, in recent years the accumulated evidence gathered in various studies and grouped in a recent systematic review suggests that endoscopic mucosal resection with cold snare (Cold-EMR) may be safer than electrocoagulation resection for both 10-19mm lesions and for lesions >20 mm, associated with a lower rate of adverse effects with similar efficacy rates in terms of complete resection and adenomatous recurrence rate. Still, evidence for the treatment of nonpedunculated lesions >20 mm is relatively limited and is not based on randomized comparative studies with the standard EMR technique.

Conditions: Adenoma Colon, Serrated Polyp, Serrated Adenoma, Colorectal Neoplasms
Being tested: Standard Endoscopic Mucosal Resection, Cold Snare Endoscopic Mucosal Resection
Keywords: endoscopic mucosal resection, cold snare endoscopic mucosal resection, standard endoscopic mucosal resection, large nonpedunculated homogeneous colorectal lesions, adenoma colon, serrated polyp, serrated adenoma, conventional endoscopic mucosal resection, laterally spreading adenomas.
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard Endoscopic Mucosal ResectionProcedure or surgery
Also called Standard EMR
Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery
Cold Snare Endoscopic Mucosal ResectionProcedure or surgery
Also called Cold EMR
Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery

Study groups in NCT04418843
Study group	Role	What they receive
Standard Endoscopic Mucosal Resection	Experimental	Standard Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (>20 mm) Receives: Procedure: Standard Endoscopic Mucosal Resection
Cold Snare Endoscopic Mucosal Resection	Experimental	Cold Snare Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (>20 mm) Receives: Procedure: Cold Snare Endoscopic Mucosal Resection

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete resection of the lesion
Complete resection of the lesion is defined as the non-visualization by the endoscopist of a residual lesion in the mucosal defect and its edge at the end of the EMR and no visualization of recurrence in the post-EMR scar on the first surveillance colonoscopy and absence of recurrence data in scar biopsies
Measured: 3-6 months

Secondary outcomes (15)

Security profile
Security profile is defined as the observed percentage of complications (Intra-procedure bleeding, deferred bleeding, deferred bleeding in antiplatelet and/or anticoagulated patients,post-polypectomy fever, post-polypectomy syndrome, deep muscle damage and perforation) in each of the evaluated techniques.
Measured: 30 days
Late adenoma recurrence rate
Late adenoma recurrence rate as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies) in surveillance colonoscopy at 18 months of the procedure
Measured: 18 months
Number of fragments needed to complete the resection
Number of fragments needed to resect with polypectomy snare to complete the resection of the colorectal lesion.
Measured: 1 day
Resection time
Time needed to perform endoscopic mucosal resection measured from first snare positioning until complete resection is achieved based on endoscopic assessment.
Measured: 1 day
Bloc resection rate
Number of lesions that have undergone resection in a single fragment with each of these evaluated techniques.
Measured: 1
R0 resection rate
Number of lesions with complete macroscopic resection with a negative microscopic margin in the mucosectomy specimen
Measured: 1 day
EMR technique conversion rate
Number of lesions to be finally resected with the other arm of study technique not initially assigned
Measured: 1 day
Need for additional treatments to complete the resection.
Number of lesions that cannot be completely resected with the assigned EMR technique, requiring different techniques to complete the resection, such as SOFT coagulation with snare tip, APC (argon plasma coagulation), hot avulsion with hot biopsy forceps, biopsy forceps, biopsy forceps +ablation
Measured: 1 day
Number of clips used
Number of clip used for hemostatic purposes or for the prophylactic closure of the injury
Measured: 1 day
Degree of artifact/interference in the histological interpretation
Subjective impression of the artifact in the histological interpretation of the resected sample (null, moderate, severe)
Measured: 1 day
Depth of the resected submucosa
Measure the depth of the resected submucosa layer (in microns) with each of the resection techniques used
Measured: 1 day
Percentage of mucosal muscle present in the mucosal protrusions in the resection defect of cold-EMR.
Assess the percentage of presence of mucosal muscle in biopsies performed on the protrusions present in the resection defect of cold-EMR
Measured: 1 day
Need for surgery for technical failure
Number of lesions that have to be finally resected by surgery due to technical impossibility for their endoscopic resection.
Measured: 6 months
Cost-effectiveness study.
evaluate the cost-effectiveness of each of the endoscopic mucosal resection techniques
Measured: 18 months
Sub-analysis by center participating in the study
A subanalysis of the study results by center will be carried out to rule out significant differences between them
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202031 Mar 2023

First posted5 Jun 2020
Study start8 Jun 2020
Primary completion31 Dec 2022
Study completion31 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Adenoma ColonStudies of the same condition, open and under way.
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: Prospective randomized study (1:1), multicenter, non-blind of consecutive non-pedunculated lesions of serrated and adenomatous histology, homogeneous, with a size greater than or equal to 20 mm (no upper limit in size). Performing cold-EMR vs standard EMR. A non-inferiority study of cold-EMR versus standard EMR.
Masking: None (open label)
Enrolment: 229 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04418843
Sponsor's protocol ID: RMEFRÍA.2019
Status last verified: Sep 2023
First submitted: 3 Jun 2020
Last updated: 28 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Thoguluva Chandrasekar V, Spadaccini M, Aziz M, Maselli R, Hassan S, Fuccio L, Duvvuri A, Frazzoni L, Desai M, Fugazza A, Jegadeesan R, Colombo M, Dasari CS, Hassan C, Sharma P, Repici A. Cold snare endoscopic resection of nonpedunculated colorectal polyps larger than 10 mm: a systematic review and pooled-analysis. Gastrointest Endosc. 2019 May;89(5):929-936.e3. doi: 10.1016/j.gie.2018.12.022. Epub 2019 Jan 9.
PubMed 30639542
Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.
PubMed 24125514
Takeuchi Y, Yamashina T, Matsuura N, Ito T, Fujii M, Nagai K, Matsui F, Akasaka T, Hanaoka N, Higashino K, Iishi H, Ishihara R, Thorlacius H, Uedo N. Feasibility of cold snare polypectomy in Japan: A pilot study. World J Gastrointest Endosc. 2015 Nov 25;7(17):1250-6. doi: 10.4253/wjge.v7.i17.1250.
PubMed 26634041
Aslan F, Camci M, Alper E, Akpinar Z, Arabul M, Celik M, Unsal B. Cold snare polypectomy versus hot snare polypectomy in endoscopic treatment of small polyps. Turk J Gastroenterol. 2014 Jun;25(3):279-83. doi: 10.5152/tjg.2014.5085.
PubMed 25141316
Tate DJ, Awadie H, Bahin FF, Desomer L, Lee R, Heitman SJ, Goodrick K, Bourke MJ. Wide-field piecemeal cold snare polypectomy of large sessile serrated polyps without a submucosal injection is safe. Endoscopy. 2018 Mar;50(3):248-252. doi: 10.1055/s-0043-121219. Epub 2017 Nov 23.
PubMed 29169195
Hirose R, Yoshida N, Murakami T, Ogiso K, Inada Y, Dohi O, Okayama T, Kamada K, Uchiyama K, Handa O, Ishikawa T, Konishi H, Naito Y, Fujita Y, Kishimoto M, Yanagisawa A, Itoh Y. Histopathological analysis of cold snare polypectomy and its indication for colorectal polyps 10-14 mm in diameter. Dig Endosc. 2017 Jul;29(5):594-601. doi: 10.1111/den.12825. Epub 2017 May 17.
PubMed 28160332
Rameshshanker R, Tsiamoulos Z, Latchford A, Moorghen M, Saunders BP. Resection of large sessile serrated polyps by cold piecemeal endoscopic mucosal resection: Serrated COld Piecemeal Endoscopic mucosal resection (SCOPE). Endoscopy. 2018 Jul;50(7):E165-E167. doi: 10.1055/a-0599-0346. Epub 2018 May 9. No abstract available.
PubMed 29742770
Rex KD, Vemulapalli KC, Rex DK. Recurrence rates after EMR of large sessile serrated polyps. Gastrointest Endosc. 2015 Sep;82(3):538-41. doi: 10.1016/j.gie.2015.01.025. Epub 2015 Apr 4.
PubMed 25851161
Qu J, Jian H, Li L, Zhang Y, Feng B, Li Z, Zuo X. Effectiveness and safety of cold versus hot snare polypectomy: A meta-analysis. J Gastroenterol Hepatol. 2019 Jan;34(1):49-58. doi: 10.1111/jgh.14464. Epub 2018 Sep 26.
PubMed 30176072
Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Endoscopy. 2016 Apr;48(4):c1. doi: 10.1055/s-0042-122686. Epub 2017 Jan 23. No abstract available.
PubMed 28114689
Burgess NG, Bassan MS, McLeod D, Williams SJ, Byth K, Bourke MJ. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut. 2017 Oct;66(10):1779-1789. doi: 10.1136/gutjnl-2015-309848. Epub 2016 Jul 27.
PubMed 27464708
Takayanagi D, Nemoto D, Isohata N, Endo S, Aizawa M, Utano K, Kumamoto K, Hojo H, Lefor AK, Togashi K. Histological Comparison of Cold versus Hot Snare Resections of the Colorectal Mucosa. Dis Colon Rectum. 2018 Aug;61(8):964-970. doi: 10.1097/DCR.0000000000001109.
PubMed 29944582
Rodriguez Sanchez J, Sanchez Alonso M, Pellise Urquiza M. The "bubble sign": a novel way to detect a perforation after cold snare polypectomy. Endoscopy. 2019 Aug;51(8):796-797. doi: 10.1055/a-0881-2856. Epub 2019 May 9. No abstract available.
PubMed 31071753
Keklikkiran C, Ozdogan OC. Thermal ablation of mucosal defect margins reduces adenoma recurrence after colonic endoscopic mucosal resection. Turk J Gastroenterol. 2019 Jun;30(6):580-581. doi: 10.5152/tjg.2019.210519. No abstract available.
PubMed 31144663
Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.
PubMed 24986245

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingPhase 1/2
Lead-212 PSV359 Therapy for Patients With Solid Tumors
Pancreatic Ductal Adenocarcinoma, Gastric Cancer
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer

All Adenoma Colon trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions.Randomized and Multicentric Clinical Trial
ClinicalTrials.gov ID: NCT04418843
Acronym / sponsor ID: RMEFRÍA.2019
Conditions: Adenoma Colon, Serrated Polyp, Serrated Adenoma, Colorectal Neoplasms
Keywords: endoscopic mucosal resection, cold snare endoscopic mucosal resection, standard endoscopic mucosal resection, large nonpedunculated homogeneous colorectal lesions, adenoma colon, serrated polyp, serrated adenoma, conventional endoscopic mucosal resection
Study type: Interventional
Recruitment status: Completed
Enrolment: 229 participants (actual)
Lead sponsor: Oscar NogalesUniversity, hospital or other
Collaborators: Spanish Society of Digestive Endoscopy
Study start: 8 Jun 2020 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Mar 2023 (actual)
First posted: 5 Jun 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Prospective randomized study (1:1), multicenter, non-blind of consecutive non-pedunculated lesions of serrated and adenomatous histology, homogeneous, with a size greater than or equal to 20 mm (no upper limit in size). Performing cold-EMR vs standard EMR. A non-inferiority study of cold-EMR versus standard EMR.

Arm	Type	Receives
Standard Endoscopic Mucosal Resection	Experimental	Procedure: Standard Endoscopic Mucosal ResectionStandard Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (>20 mm)
Cold Snare Endoscopic Mucosal Resection	Experimental	Procedure: Cold Snare Endoscopic Mucosal ResectionCold Snare Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (>20 mm)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients of age > 18 years undergoing a colonoscopy for any reason of request and who do not meet exclusion criteria.
Nonpedunculated homogeneous colorectal lesions type LST ( Paris 0-IIa morphology) and serrated lesions larger than 20 mm without endoscopic data of malignancy: NICE 1 pattern +/- NICE 2 component ( serrated lesions) or NICE2 pattern/JNET 2A (adenomas) and therefore subsidiaries of RME. Randomization will be performed per patient, not for colorectal lesions
Signature of informed consent of endoscopic exploration

Key exclusion criteria (11 listed)

.No signature of informed consent prior to the study procedure.
Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations (BSG and ESGE guidelines)
Patients with severe thrombopenia/ coagulopathy (Platelets < 50,000/INR > 1.5) not corrected prior to procedure (plasma or platelet transfusion)
Patients not candidates for endoscopic resection of colorectal lesions by comorbidities.
Pregnant.

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
Standard Endoscopic Mucosal ResectionAlso: Standard EMRUse of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery	Procedure or surgery	Standard Endoscopic Mucosal Resection
Cold Snare Endoscopic Mucosal ResectionAlso: Cold EMRUse of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery	Procedure or surgery	Cold Snare Endoscopic Mucosal Resection

Primary outcome

Complete resection of the lesion
Time frame: 3-6 months
Complete resection of the lesion is defined as the non-visualization by the endoscopist of a residual lesion in the mucosal defect and its edge at the end of the EMR and no visualization of recurrence in the post-EMR scar on the first surveillance colonoscopy and absence of recurrence data in scar biopsies

15 secondary outcomes

Security profile
Time frame: 30 days
Late adenoma recurrence rate
Time frame: 18 months
Number of fragments needed to complete the resection
Time frame: 1 day
Resection time
Time frame: 1 day
Bloc resection rate
Time frame: 1
R0 resection rate
Time frame: 1 day
EMR technique conversion rate
Time frame: 1 day
Need for additional treatments to complete the resection.
Time frame: 1 day
Number of clips used
Time frame: 1 day
Degree of artifact/interference in the histological interpretation
Time frame: 1 day
Depth of the resected submucosa
Time frame: 1 day
Percentage of mucosal muscle present in the mucosal protrusions in the resection defect of cold-EMR.
Time frame: 1 day
Need for surgery for technical failure
Time frame: 6 months
Cost-effectiveness study.
Time frame: 18 months
Sub-analysis by center participating in the study
Time frame: 18 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Background: PubMed 30639542Thoguluva Chandrasekar V, Spadaccini M, Aziz M, Maselli R, Hassan S, Fuccio L, Duvvuri A, Frazzoni L, Desai M, Fugazza A, Jegadeesan R, Colombo M, Dasari CS, Hassan C, Sharma P, Repici A. Cold snare endoscopic resection of nonpedunculated colorectal polyps larger than 10 mm: a systematic review and pooled-analysis. Gastrointest Endosc. 2019 May;89(5):929-936.e3. doi: 10.1016/j.gie.2018.12.022. Epub 2019 Jan 9.
Background: PubMed 24125514Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.
Background: PubMed 26634041Takeuchi Y, Yamashina T, Matsuura N, Ito T, Fujii M, Nagai K, Matsui F, Akasaka T, Hanaoka N, Higashino K, Iishi H, Ishihara R, Thorlacius H, Uedo N. Feasibility of cold snare polypectomy in Japan: A pilot study. World J Gastrointest Endosc. 2015 Nov 25;7(17):1250-6. doi: 10.4253/wjge.v7.i17.1250.
Background: PubMed 25141316Aslan F, Camci M, Alper E, Akpinar Z, Arabul M, Celik M, Unsal B. Cold snare polypectomy versus hot snare polypectomy in endoscopic treatment of small polyps. Turk J Gastroenterol. 2014 Jun;25(3):279-83. doi: 10.5152/tjg.2014.5085.
Background: PubMed 29169195Tate DJ, Awadie H, Bahin FF, Desomer L, Lee R, Heitman SJ, Goodrick K, Bourke MJ. Wide-field piecemeal cold snare polypectomy of large sessile serrated polyps without a submucosal injection is safe. Endoscopy. 2018 Mar;50(3):248-252. doi: 10.1055/s-0043-121219. Epub 2017 Nov 23.
Background: PubMed 28160332Hirose R, Yoshida N, Murakami T, Ogiso K, Inada Y, Dohi O, Okayama T, Kamada K, Uchiyama K, Handa O, Ishikawa T, Konishi H, Naito Y, Fujita Y, Kishimoto M, Yanagisawa A, Itoh Y. Histopathological analysis of cold snare polypectomy and its indication for colorectal polyps 10-14 mm in diameter. Dig Endosc. 2017 Jul;29(5):594-601. doi: 10.1111/den.12825. Epub 2017 May 17.
Background: PubMed 29742770Rameshshanker R, Tsiamoulos Z, Latchford A, Moorghen M, Saunders BP. Resection of large sessile serrated polyps by cold piecemeal endoscopic mucosal resection: Serrated COld Piecemeal Endoscopic mucosal resection (SCOPE). Endoscopy. 2018 Jul;50(7):E165-E167. doi: 10.1055/a-0599-0346. Epub 2018 May 9. No abstract available.
Background: PubMed 25851161Rex KD, Vemulapalli KC, Rex DK. Recurrence rates after EMR of large sessile serrated polyps. Gastrointest Endosc. 2015 Sep;82(3):538-41. doi: 10.1016/j.gie.2015.01.025. Epub 2015 Apr 4.
Background: PubMed 30176072Qu J, Jian H, Li L, Zhang Y, Feng B, Li Z, Zuo X. Effectiveness and safety of cold versus hot snare polypectomy: A meta-analysis. J Gastroenterol Hepatol. 2019 Jan;34(1):49-58. doi: 10.1111/jgh.14464. Epub 2018 Sep 26.
Background: PubMed 28114689Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Endoscopy. 2016 Apr;48(4):c1. doi: 10.1055/s-0042-122686. Epub 2017 Jan 23. No abstract available.
Background: PubMed 27464708Burgess NG, Bassan MS, McLeod D, Williams SJ, Byth K, Bourke MJ. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut. 2017 Oct;66(10):1779-1789. doi: 10.1136/gutjnl-2015-309848. Epub 2016 Jul 27.
Background: PubMed 29944582Takayanagi D, Nemoto D, Isohata N, Endo S, Aizawa M, Utano K, Kumamoto K, Hojo H, Lefor AK, Togashi K. Histological Comparison of Cold versus Hot Snare Resections of the Colorectal Mucosa. Dis Colon Rectum. 2018 Aug;61(8):964-970. doi: 10.1097/DCR.0000000000001109.
Individual participant dataSharing planned: No

Related trials for Adenoma Colon

RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingPhase 1/2
Lead-212 PSV359 Therapy for Patients With Solid Tumors
Pancreatic Ductal Adenocarcinoma, Gastric Cancer
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer

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.

Oscar Nogales principal investigator

Hospital General Universitario Gregorio Marañon

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standard Endoscopic Mucosal Resection and Cold Snare Endoscopic Mucosal Resection in people with Adenoma Colon and Serrated Polyp, run by Oscar Nogales at 1 site in Spain.

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 3 inclusion and 11 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: finished, as of the sponsor's last update on 28 Sep 2023. 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 Spain. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete resection of the lesion (time frame: 3-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04418843, which also lists 16 linked publications.

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 28 Sep 2023.