Colonic PolypsNCT02479893
Cold Snare,Hot Snare and APC Polypectomy for the Complete Removal of Small Left Sided Colon Polyps
An observational study of Colonic Polyps, run by Evangelismos Hospital at 1 site in Greece.
Trial summary
Given the limited existing data regarding the advantages and limitations of the existing techniques in the removal of colonic polyps the investigators designed a prospective study in order to compare cold snare vs hot snare vs argon plasma coagulation for the compete removal of colonic polyps of the left colon up to a… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- polypectomy
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2015to 10 Mar 2020
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with colonic left sided small polyps
Who may be able to join
- All consecutive patients with colorectal polyps of the left colon (up to the splenic flexure) with a diameter of 0.3-0.8cm.
Who cannot join
- The study excluded patients with a history of familial polyposis (FAP), Gardner's syndrome, Peutz-Jeghers syndrome, patients with colon Cancer as well as patients with idiopathic inflammatory bowel disease (IBD).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cold Snare Polypectomy vs Hot Snare Polypectomy vs APC for the Complete Removal of Left Sided Colon Polyps. A Prospective,Randomized Trial
Given the limited existing data regarding the advantages and limitations of the existing techniques in the removal of colonic polyps the investigators designed a prospective study in order to compare cold snare vs hot snare vs argon plasma coagulation for the compete removal of colonic polyps of the left colon up to a diameter of 0.8cm.
Read the detailed description
Adenomatous polyps are the most common neoplastic findings discovered in subjects who undergo colonoscopy either for colorectal screening or during a diagnostic work-up for symptoms.
Currently small polyps 0.3-0.8cm are removed using hot snare polypectomy (HSP) cold snare polypectomy (CSP) while argon plasma coagulation (APC) has been proposed for the cauterization of bigger polyps ("Melt Effect") Endoscopic polypectomy is associated with potential complications, i.e. perforation and bleeding while some polyps may recur after polypectomy.
Given the limited existing data regarding the advantages and limitations of the existing techniques in the removal of colonic polyps the investigators designed a prospective study in order to compare the above mentioned methods for the compete removal of colonic polyps 0,3-0,8 cm from the left side colon.
METHODS The study will be conducted in the endoscopy unit of "Evangelismos" Hospital and in D Surgical clinic of the University Hospital "Attikon".All consecutive patients with colorectal polyps of the left colon (up to the splenic flexure) with a diameter of 0.3-0.8cm will be prospectively randomized to three groups.
- CSP: In this group polyps will be removed with the cold snare polypectomy technique, as a single piece. Additionally, a 1-2mm of normal tissue around the small polyp will also be ensnared in the CSP.
- HSP: In this group polyps will be removed with the hot snare polypectomy technique as a single piece with a electrosurgical snare and monopolar current with a setting of 30-35 W in the endocut function.
- APC: In APC group polyps will be cauterized by application of high power argon plasma coagulation on small waves at 50-60W and flow at 2lt/min.
All polyps will be elevated by submucosal injection of normal saline (1ml) and consequently a special dye (1ml) containing carbon particles (Spot) before applying any of the three removal techniques.
The injection solution protects from thermal injury of deeper layers during the application of current and APC,also the injection of the dye (tattoo) at the polypectomy, ensures that the endoscopist will detect the point of polypectomy in the follow up colonoscopy after 3-6 months.
Spot (GI supply,Camp Hill,PA) is the only commercially available suspension for endoscopic tattooing approved by the Food and Drug Association (FDA). It contains prediluted sterile syrings that are filled with highly purified fine carbon particles ready for endoscopic use.
The study excluded patients with a history of familial polyposis (FAP), Gardner's syndrome, Peutz-Jeghers syndrome, patients with colon Cancer as well as patients with idiopathic inflammatory bowel disease (IBD).
Statistical analysis showed that the sample required to give medium (W = 0.3) the difference between the three groups is 108 patients, with significance level of 5% and validity of the study 80% All patients included in the study will undergo a repeat colonoscopy in a 3-6 month time period. The endoscopist based on tattoos have been received on the first endoscopy during polypectomy will receive multiple biopsies from the point, which will be sent for histological examination.The pathologist will then examine the tissue sample and will define whereas the polyp has been completely eradicated or recurred.
- Conditions
- Colonic Polyps
- Being tested
- polypectomy
- Keywords
- cold snare polypectomy, APC, hot snare polypectomy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polypectomyProcedure or surgery
Also called sigmoidoscopy, colonoscopy
Polyps size up to 0.8 cm will removed from the left colon.Re examination in 6 months period with biopsy from the scar of polypectomy.
| Study group | Role | What they receive |
|---|---|---|
| cold snare polypectomy | CSP: In this group polyps will be removed with the cold snare polypectomy technique, as a single piece. Additionally, a 1-2mm of normal tissue around the small polyp will also be ensnared in the CSP. Receives: Procedure: polypectomy | |
| hot snare polypectomy | HSP: In this group polyps will be removed with the hot snare polypectomy technique as a single piece with a electrosurgical snare and monopolar current with a setting of 30-35 W in the endocut function. Receives: Procedure: polypectomy | |
| APC polyp destruction-polypectomy | APC: In APC group polyps will be cauterized by application of high power argon plasma coagulation on small waves at 50-60W and flow at 2lt/min,as result the polyp destruction. Receives: Procedure: polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete removal of colonic polyps
The resections margin of the polyp was isolated from the rest of the polyp,stained with black and examined through multiple histological sections in order to certify that no dysplastic cells were traced upon the resection margin.Since all adenoma cases exhibited low grade epithelial dysplasia, as positive margin was considered the presence of dysplastic cell exactly upon the resection margin/black ink.
Measured: at 6 months after polypectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2019
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Attikon Hospital
- Responsible party
- Principal investigator, Nikos Viazis, Evangelismos Hospital
- Investigators
- Nikos Viazis, Director, Principal investigator, Evangelismos Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479893
- Sponsor's protocol ID
- 80/30-04-2015
- Status last verified
- May 2020
- First submitted
- 26 May 2015
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Schneider R, Goldman AB, Insall JN. Knee prostheses. Semin Roentgenol. 1986 Jan;21(1):29-46. doi: 10.1016/0037-198x(86)90007-6. No abstract available.
PubMed 3513321Tolliver KA, Rex DK. Colonoscopic polypectomy. Gastroenterol Clin North Am. 2008 Mar;37(1):229-51, ix. doi: 10.1016/j.gtc.2007.12.009.
PubMed 18313548Uno Y, Obara K, Zheng P, Miura S, Odagiri A, Sakamoto J, Munakata A. Cold snare excision is a safe method for diminutive colorectal polyps. Tohoku J Exp Med. 1997 Dec;183(4):243-9. doi: 10.1620/tjem.183.243.
PubMed 9549824Winawer SJ, Zauber AG, Fletcher RH, Stillman JS, O'Brien MJ, Levin B, Smith RA, Lieberman DA, Burt RW, Levin TR, Bond JH, Brooks D, Byers T, Hyman N, Kirk L, Thorson A, Simmang C, Johnson D, Rex DK; US Multi-Society Task Force on Colorectal Cancer; American Cancer Society. Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society. Gastroenterology. 2006 May;130(6):1872-85. doi: 10.1053/j.gastro.2006.03.012.
PubMed 16697750Metz AJ, Moss A, McLeod D, Tran K, Godfrey C, Chandra A, Bourke MJ. A blinded comparison of the safety and efficacy of hot biopsy forceps electrocauterization and conventional snare polypectomy for diminutive colonic polypectomy in a porcine model. Gastrointest Endosc. 2013 Mar;77(3):484-90. doi: 10.1016/j.gie.2012.09.014. Epub 2012 Nov 27.
PubMed 23199650Tsiamoulos ZP, Bourikas LA, Saunders BP. Endoscopic mucosal ablation: a new argon plasma coagulation/injection technique to assist complete resection of recurrent, fibrotic colon polyps (with video). Gastrointest Endosc. 2012 Feb;75(2):400-4. doi: 10.1016/j.gie.2011.09.003. Epub 2011 Dec 7.
PubMed 22154411Anderloni A, Jovani M, Hassan C, Repici A. Advances, problems, and complications of polypectomy. Clin Exp Gastroenterol. 2014 Aug 30;7:285-96. doi: 10.2147/CEG.S43084. eCollection 2014.
PubMed 25210470Varytimiadis L, Viazis N, Gkolfakis P, Tribonias G, Tziatzios G, Kyriakopoulos G, Argyrakos T, Pontas C, Papastergiou V, Arkadopoulos N, Smyrniotis V, Mantzaris GJ, Papanikolaou IS. Cold snare polypectomy vs. hot snare polypectomy vs. argon plasma coagulation for small (5-9mm) left-sided colorectal polyps: a prospective randomized trial. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e909-e915. doi: 10.1097/MEG.0000000000002300.
PubMed 35048657
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Snare Polypectomy vs Hot Snare Polypectomy vs APC for the Complete Removal of Left Sided Colon Polyps. A Prospective,Randomized Trial
- ClinicalTrials.gov ID
- NCT02479893
- Acronym / sponsor ID
- 80/30-04-2015
- Conditions
- Colonic Polyps
- Keywords
- cold snare polypectomy, APC, hot snare polypectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Collaborators
- Attikon Hospital
- Study start
- Jan 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 24 Jun 2015 (estimated)
- 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.
Given the limited existing data regarding the advantages and limitations of the existing techniques in the removal of colonic polyps the investigators designed a prospective study in order to compare cold snare vs hot snare vs argon plasma coagulation for the compete removal of colonic polyps of the left colon up to a diameter of 0.8cm.
Detailed description
Adenomatous polyps are the most common neoplastic findings discovered in subjects who undergo colonoscopy either for colorectal screening or during a diagnostic work-up for symptoms.
Currently small polyps 0.3-0.8cm are removed using hot snare polypectomy (HSP) cold snare polypectomy (CSP) while argon plasma coagulation (APC) has been proposed for the cauterization of bigger polyps ("Melt Effect") Endoscopic polypectomy is associated with potential complications, i.e. perforation and bleeding while some polyps may recur after polypectomy.
Given the limited existing data regarding the advantages and limitations of the existing techniques in the removal of colonic polyps the investigators designed a prospective study in order to compare the above mentioned methods for the compete removal of colonic polyps 0,3-0,8 cm from the left side colon.
METHODS The study will be conducted in the endoscopy unit of "Evangelismos" Hospital and in D Surgical clinic of the University Hospital "Attikon".All consecutive patients with colorectal polyps of the left colon (up to the splenic flexure) with a diameter of 0.3-0.8cm will be prospectively randomized to three groups.
- CSP: In this group polyps will be removed with the cold snare polypectomy technique, as a single piece. Additionally, a 1-2mm of normal tissue around the small polyp will also be ensnared in the CSP.
- HSP: In this group polyps will be removed with the hot snare polypectomy technique as a single piece with a electrosurgical snare and monopolar current with a setting of 30-35 W in the endocut function.
- APC: In APC group polyps will be cauterized by application of high power argon plasma coagulation on small waves at 50-60W and flow at 2lt/min.
All polyps will be elevated by submucosal injection of normal saline (1ml) and consequently a special dye (1ml) containing carbon particles (Spot) before applying any of the three removal techniques.
The injection solution protects from thermal injury of deeper layers during the application of current and APC,also the injection of the dye (tattoo) at the polypectomy, ensures that the endoscopist will detect the point of polypectomy in the follow up colonoscopy after 3-6 months.
Spot (GI supply,Camp Hill,PA) is the only commercially available suspension for endoscopic tattooing approved by the Food and Drug Association (FDA). It contains prediluted sterile syrings that are filled with highly purified fine carbon particles ready for endoscopic use.
The study excluded patients with a history of familial polyposis (FAP), Gardner's syndrome, Peutz-Jeghers syndrome, patients with colon Cancer as well as patients with idiopathic inflammatory bowel disease (IBD).
Statistical analysis showed that the sample required to give medium (W = 0.3) the difference between the three groups is 108 patients, with significance level of 5% and validity of the study 80% All patients included in the study will undergo a repeat colonoscopy in a 3-6 month time period. The endoscopist based on tattoos have been received on the first endoscopy during polypectomy will receive multiple biopsies from the point, which will be sent for histological examination.The pathologist will then examine the tissue sample and will define whereas the polyp has been completely eradicated or recurred.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cold snare polypectomy | – | Procedure: polypectomyCSP: In this group polyps will be removed with the cold snare polypectomy technique, as a single piece. Additionally, a 1-2mm of normal tissue around the small polyp will also be ensnared in the CSP. |
| hot snare polypectomy | – | Procedure: polypectomyHSP: In this group polyps will be removed with the hot snare polypectomy technique as a single piece with a electrosurgical snare and monopolar current with a setting of 30-35 W in the endocut function. |
| APC polyp destruction-polypectomy | – | Procedure: polypectomyAPC: In APC group polyps will be cauterized by application of high power argon plasma coagulation on small waves at 50-60W and flow at 2lt/min,as result the polyp destruction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with colonic left sided small polyps
Key inclusion criteria (1 listed)
- All consecutive patients with colorectal polyps of the left colon (up to the splenic flexure) with a diameter of 0.3-0.8cm.
Key exclusion criteria (1 listed)
- The study excluded patients with a history of familial polyposis (FAP), Gardner's syndrome, Peutz-Jeghers syndrome, patients with colon Cancer as well as patients with idiopathic inflammatory bowel disease (IBD).
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 |
|---|---|---|
| polypectomyAlso: sigmoidoscopy, colonoscopyPolyps size up to 0.8 cm will removed from the left colon.Re examination in 6 months period with biopsy from the scar of polypectomy. | Procedure or surgery | APC polyp destruction-polypectomy, cold snare polypectomy, hot snare polypectomy |
Primary outcome
Complete removal of colonic polyps
Time frame: at 6 months after polypectomy
The resections margin of the polyp was isolated from the rest of the polyp,stained with black and examined through multiple histological sections in order to certify that no dysplastic cells were traced upon the resection margin.Since all adenoma cases exhibited low grade epithelial dysplasia, as positive margin was considered the presence of dysplastic cell exactly upon the resection margin/black ink.
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 11 May 2020.
- Background: PubMed 3513321Schneider R, Goldman AB, Insall JN. Knee prostheses. Semin Roentgenol. 1986 Jan;21(1):29-46. doi: 10.1016/0037-198x(86)90007-6. No abstract available.
- Background: PubMed 18313548Tolliver KA, Rex DK. Colonoscopic polypectomy. Gastroenterol Clin North Am. 2008 Mar;37(1):229-51, ix. doi: 10.1016/j.gtc.2007.12.009.
- Background: PubMed 9549824Uno Y, Obara K, Zheng P, Miura S, Odagiri A, Sakamoto J, Munakata A. Cold snare excision is a safe method for diminutive colorectal polyps. Tohoku J Exp Med. 1997 Dec;183(4):243-9. doi: 10.1620/tjem.183.243.
- Background: PubMed 16697750Winawer SJ, Zauber AG, Fletcher RH, Stillman JS, O'Brien MJ, Levin B, Smith RA, Lieberman DA, Burt RW, Levin TR, Bond JH, Brooks D, Byers T, Hyman N, Kirk L, Thorson A, Simmang C, Johnson D, Rex DK; US Multi-Society Task Force on Colorectal Cancer; American Cancer Society. Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society. Gastroenterology. 2006 May;130(6):1872-85. doi: 10.1053/j.gastro.2006.03.012.
- Background: PubMed 23199650Metz AJ, Moss A, McLeod D, Tran K, Godfrey C, Chandra A, Bourke MJ. A blinded comparison of the safety and efficacy of hot biopsy forceps electrocauterization and conventional snare polypectomy for diminutive colonic polypectomy in a porcine model. Gastrointest Endosc. 2013 Mar;77(3):484-90. doi: 10.1016/j.gie.2012.09.014. Epub 2012 Nov 27.
- Background: PubMed 22154411Tsiamoulos ZP, Bourikas LA, Saunders BP. Endoscopic mucosal ablation: a new argon plasma coagulation/injection technique to assist complete resection of recurrent, fibrotic colon polyps (with video). Gastrointest Endosc. 2012 Feb;75(2):400-4. doi: 10.1016/j.gie.2011.09.003. Epub 2011 Dec 7.
- Background: PubMed 25210470Anderloni A, Jovani M, Hassan C, Repici A. Advances, problems, and complications of polypectomy. Clin Exp Gastroenterol. 2014 Aug 30;7:285-96. doi: 10.2147/CEG.S43084. eCollection 2014.
- Derived from this study: PubMed 35048657Varytimiadis L, Viazis N, Gkolfakis P, Tribonias G, Tziatzios G, Kyriakopoulos G, Argyrakos T, Pontas C, Papastergiou V, Arkadopoulos N, Smyrniotis V, Mantzaris GJ, Papanikolaou IS. Cold snare polypectomy vs. hot snare polypectomy vs. argon plasma coagulation for small (5-9mm) left-sided colorectal polyps: a prospective randomized trial. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e909-e915. doi: 10.1097/MEG.0000000000002300.
- Individual participant dataSharing planned: Undecided
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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.
Nikos Viazis, Director principal investigator
Evangelismos Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyps, run by Evangelismos Hospital at 1 site in Greece.
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 1 inclusion and 1 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 11 May 2020. 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 Greece. 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 removal of colonic polyps (time frame: at 6 months after polypectomy). 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 NCT02479893, which also lists 8 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 11 May 2020.