Colorectal Polyps, Endoscopic Mucosal Resection
Conditions
Brief summary
This multicenter, prospective, randomized, non-inferiority trial aimed to compare the efficacy and safety of cold snare endoscopic mucosal resection (CS-EMR) and hot snare endoscopic mucosal resection (HS-EMR) for resection of intermediate-size (10-20 mm) flat nonpedunculated colorectal polyps.
Interventions
PROCEDURECold snare endoscopic mucosal resection (CS-EMR)
During CS-EMR, methylene blue-stained epinephrine saline is injected into the submucosa surrounding the lesion to achieve submucosal lifting. The polyp together with 1-2 mm of adjacent mucosa is subsequently tightly snared and mechanically transected.
PROCEDUREHot snare endoscopic mucosal resection (HS-EMR)
During HS-EMR, methylene blue-stained epinephrine saline is injected into the submucosa surrounding the lesion to achieve submucosal lifting. The snare is positioned around the lesion, and electrocautery is delivered via the electrosurgical generator for transection.
Sponsors
Nanfang Hospital, Southern Medical University
Shunde First People's Hospital of Foshan
Jiangmen Central Hospital
ZhuHai Hospital
Longgang District People's Hospital of Shenzhen
Yangjiang People's Hospital
The Third People's Hospital of Huizhou
Longnan Traditional Chinese Medicine Hospital
Sihui Wanlong Hospital
Suixi People's Hospital of Zhanjiang
Guzhen People's Hospital of Zhongshan
Anyuan County People's Hospital of Ganzhou
Shaoguan First People's Hospital
Yangchun People's Hospital
ZhuZhou Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged 18-75 years, irrespective of gender; 2. Flat sessile colorectal polyps confirmed by colonoscopy, classified as Paris classification 0-Is or 0-IIa, with a measured diameter ranging from 10 to 20 mm; 3. Subjects voluntarily agree to receive endoscopic treatment and sign written informed consent.
Exclusion criteria
1. Colonoscopic findings suggestive of submucosal invasion or malignant transformation of colorectal polyps; 2. Previous history of colorectal surgery; 3. Previous history of inflammatory bowel disease, familial adenomatous polyposis, or colorectal cancer; 4. Failure to discontinue anticoagulant and antiplatelet medications for a minimum of 1 week prior to the procedure; 5. Known coagulation disorders or bleeding diathesis; 6. Pregnant or breastfeeding women; 7. Patients complicated with malignant tumors, severe cardiovascular and cerebrovascular diseases, liver cirrhosis, chronic kidney disease, or other severe comorbidities that preclude tolerance to endoscopic resection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete resection rate | Within 14 days | All five biopsy specimens harvested from the resection margins after EMR resection yielded negative pathological findings. These five biopsy samples consisted of four specimens collected from the four quadrants of the resection wound margin and one specimen obtained from the wound base. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| en bloc resection rate | Within one days | The lesion was completely excised under endoscope and a single specimen was obtained. |
| Unresectable rate of CS-EMR | Within one day | A resection procedure that needed high-frequency electric current. |
| Intraprocedural bleeding | Within one day | Intraoperative arterial bleeding or active mucosal oozing lasting more than 30 seconds that requires endoscopic hemostatic intervention. |
| Intraprocedural perforation | Within one day | Endoscopic observation of perforation requiring sealing with clips |
| Procedural time | Within one day | The duration from the first occurrence of injection needle under endoscope visual field to complete removal of the resected polyp |
| Delayed bleeding | Within 14 days | haemorrhage after colonoscopy requiring endoscopic haemostasis with 14 days. |
| Delayed perforation | Within 14 days | Any perforation within 14 days |
| Number of clips used | Within one day | The number of clips used for each resected polyp |
Contacts
CONTACTZelong Han, MD
CONTACTBitao Lin, MD
Outcome results
None listed