Cold Snare Resection, Hot Snare Resection, Polyps of Colon
Conditions
Keywords
cold snare resection, hot snare resection, colorectal Polyps
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREcold 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.
PROCEDUREhot snare polypectomy
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.
Sponsors
Jinshan Hospital Fudan University
Second Affiliated Hospital of Soochow University
The Third People's Hospital Yunnan
People's Hospital Mojiang
Shanghai Yueyang Integrated Medicine Hospital
Huadong Hospital
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-80 years old, male or female 2. At least one polyp with size of 4-9 mm 0-Isp or 0-Ip is found during colonoscopy 3. Voluntarily sign informed consent for endoscopic treatment
Exclusion criteria
1. Boston Bowel Preparation Scale\<6 points. 2. Patients who receive antiplatelet/anticoagulant therapy within 5 days before polypectomy. 3. Participants with a contraindication to colonoscopy and polypectomy. 4. Patients with inflammatory bowel disease or gastrointestinal polyposis. 5. Lesions with submucosal invasion and those suspected of being cancerous at the preprocedural diagnostic evaluation. 6. Patients with pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete resection rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative bleeding rate | 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. |
| En bloc resection rate | 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 |
| Postoperative delayed bleeding rate | Up to 14 days from operation day | Incidence of bleeding requiring endoscopic hemostasis intervention within 14 days after surgery |
| Other related postoperative complications | Up to 48 Hours from the time the polyp is resected | Perforation, infection, electrocoagulation syndrome, etc |
| Number of metal clips used | The time when the operation is completed | Whether metal clips are used for hemostasis, and the number of metal clips |
| Operation time | 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 |
Countries
China
Contacts
Primary ContactTaojing Ran, MD
Outcome results
None listed