Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
NCT Number: NCT06658561
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200025, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Other names: HSP
Time frame: Up to 5-7 days from operation day
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 14 days from operation day
Incidence of bleeding requiring endoscopic hemostasis intervention within 14 days after surgery
Time frame: Up to 1 minute from the time the polyp is resected
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 7 days when the pathologists finish the evaluations.
The lesion is removed at one time, and the integrity of the specimen is maintained
Time frame: From the snare/ injection needle exits the working channel to leaving the wound.
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: Up to 48 Hours from the time the polyp is resected
Perforation, infection, electrocoagulation syndrome, etc
Time frame: The time when the operation is completed
Whether metal clips are used for hemostasis, and the number of metal clips
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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