An interventional study of cold snare polypectomy and hot snare polypectomy in Cold Snare Resection, Hot Snare Resection and Polyps of Colon, sponsored by Ruijin Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
This study will evaluate the efficacy and safety of cold snare polypectomy(CSP) and hot snare polypectomy(HSP) in the treatment of colorectal 4-9mm 0-Isp and 0-Ip polyps, and compare the complete resection rate, postoperative late bleeding rate, intraoperative bleeding rate, en bloc resection rate, operation time and the number of metal clips used. The conclusion of this study will help clinical doctor develop more effective resection strategies for colorectal 0-Isp and 0-Ip polyps, and provide more effective treatment for patients.
Colorectal polyps are one of the precancerous lesions of colorectal cancer, 60-80% of which eventually become advanced colorectal cancer. Therefore, early resection of colorectal polyps can effectively reduce the incidence of colorectal cancer. Polyps under white light are judged mainly according to the shape, size and color of polyps. At present, the Paris classification is often used to divide 0-I uplifted polyps into sessile polyps (0-Is), sessile-pedunculated polyps (0-Isp) and pedunculated polyps (0-Ip). It is generally believed that there are thick arteries in 0-Ip polyps, especially thick pedunculated polyps, which are prone to uncontrollable bleeding during operation. 0-Is polyps have small scattered blood vessels and low intraoperative bleeding risk, while the morphological and structural characteristics of 0-Isp polyps are between the two. The current guidelines recommend HSP for 0-Isp and 0-Ip polyps \<1 cm, but the internal blood vessels of these polyps are not thick. There is no guidance on whether they can be resected by CSP method, and there is a lack of prospective large sample clinical research. This study will include0-Isp /0-Ip polyps \<1cm, and observe the safety and effectiveness of CSP for the above polyp resection , so as to provide reference for the clinical treatment of colorectal polyps.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 982 is above the median of 274 across 250 interventional studies indexed under Colonic Polyps.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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1. Rotate the lens body to make the polyp at about 6 o'clock. 2. Place the special cold snare in the normal mucosa 1-2mm away from the polyp edge. 3. Tighten the snare at a constant speed and gently lift it up. 4. Excision. 5. According to the polyp size, use the colonoscope suction channel or directly use the snare to pull out the tissue for further pathological examination. 6. Piecemeal resection will be performed if the en-bloc resection fails.
Procedure: cold snare polypectomy
1. Rotate the lens body to make the polyp at about 6 o'clock. 2. According to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection. 3. Tighten the snare at a constant speed and gently lift it up. 4. Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off. 5. According to the polyp size, use the colonoscope suction channel or directly use the snare to pull out the tissue for further pathological examination. 6. Piecemeal resection will be performed if the en-bloc resection fails.
Procedure: hot snare polypectomy
Place the special cold snare in the normal mucosa 1-2mm away from the polyp edge. Tighten the snare at a constant speed and gently lift it up and then excision.
Also known as: CSP
According to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection. Tighten the snare at a constant speed and gently lift it up.Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off.
Also known as: HSP
Complete resection rate
The polyps and the two biopsies from the margin will be sent to the pathologist for further analysis. Two independent experienced pathologists will evaluate the samples separately and both are blinded to the technique performed for polypectomy. Complete resection rate is defined as the negative pathological evaluation of two biopsies obtained from the margin.
Time frame: Up to 5-7 days from operation day
Postoperative delayed bleeding rate
Incidence of bleeding requiring endoscopic hemostasis intervention within 14 days after surgery
Time frame: Up to 14 days from operation day
Intraoperative bleeding rate
Immediate bleeding is defined as bleeding persists \>60s after polypectomy according to the ESGE recommendations (2017) and requires for endoscopic intervention.
Time frame: Up to 1 minute from the time the polyp is resected
En bloc resection rate
The lesion is removed at one time, and the integrity of the specimen is maintained
Time frame: Up to 7 days when the pathologists finish the evaluations.
Operation time
CSP: the time from the time the snare exits the working channel to leaving the wound. Hsp: time from the injection needle leaving the working channel to leaving the wound
Time frame: From the snare/ injection needle exits the working channel to leaving the wound.
Other related postoperative complications
Perforation, infection, electrocoagulation syndrome, etc
Time frame: Up to 48 Hours from the time the polyp is resected
Number of metal clips used
Whether metal clips are used for hemostasis, and the number of metal clips
Time frame: The time when the operation is completed
Plan to share: No
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