Duodenal Tumor
Conditions
Brief summary
There is currently no reliable evidence on the safety of CSP (cold snare polypectomy) / p-CSP (piecemeal CSP) for SNADT greater than 6mm.In this prospective historical controlled study, we intend to test the role of CSP / p-CSP in the treatment of pedicle less snadt greater than 6mm compared with EMR (endoscopic mucosal resection) / EPMR (endoscopic piecemeal mucosal resection).
Detailed description
Due to the possibility of malignant transformation of duodenal adenomatous lesions, endoscopic resection is recommended as far as possible. The European Society of endoscopy guidelines recommend cold snare polypectomy for superficial non ampullary duodenal tumors (SNADT) less than 6mm in diameter, while EMR (endoscopic mucosal resection) is recommended as a first-line endoscopic resection for other larger lesions. ESD (endoscopic submucosal dissection) is not considered as the standard treatment of duodenum due to its difficult operation and high complication rate. In recent years, CSP (cold snare polypectomy) has been widely used in the colon. CSP is a safe alternative method of directly removing polyps with snare without electrifying. Reducing electrocoagulation can reduce the damage of peripheral blood vessels and intestinal wall, leading to decreased risk of delayed bleeding and perforation. CSP has gradually replaced EMR in the resection of colorectal lesions of appropriate size. So far, there is no reliable evidence on the safety of CSP / p-CSP (piecemeal CSP) for SNADT greater than 6mm.In this prospective historical controlled study, we intend to test the role of CSP / p-CSP in the treatment of pedicle less snadt greater than 6mm compared with EMR / EPMR (endoscopic piecemeal mucosal resection).
Interventions
PROCEDUREEndoscopic resection: CSP/p-CSP
Patients in the experimental arm will be assigned to receive CSP/p-CSP.
PROCEDUREEndoscopic resection: EMR/EPMR
Patients in the historical control arm have already finished EMR/EPMR
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Experimental arm: CSP/p-CSP 1. Patients of age 18-75 years. 2. Lesion located in the duodenum. 3. Superficial non-ampullary duodenal tumors (SNADTs) (\>6mm, Sessile). 4. Written informed consent. 5. Benign adenomatous surface features (Kudo III / IV, JNET(Japan NBI (narrow-band imaging) Expert Team) 2a). Control arm: EMR/EPMR 1. Patients of age 18-75 years. 2. Lesion located in the duodenum. 3. Superficial non-ampullary duodenal tumors (SNADTs) (\>6mm, Sessile). 4. Benign adenomatous surface features (Kudo III / IV, JNET 2a). 5. Received EMR/EPMR already. 6. Provided written informed consent for use of clinical information.
Exclusion criteria
Experimental arm: CSP/p-CSP 1. Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations according to the guidelines, or presence of coagulation disorder （PLT (platelet)\<50×10\^9 / L or INR (international normalized ratio)≥1.5) at the time of EMR/EPMR. 2. History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy at the time of EMR/EPMR. 3. Pregnant or breast feeding at the time of EMR/EPMR. 4. Lesions involving the ampullary area. 5. Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3). 6. Scar of previous endoscopic procedures within 10mm around the lesion. Control arm: EMR/EPMR 1. Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations according to the guidelines, or presence of coagulation disorder （PLT\<50×10\^9 / L or INR≥1.5)；. 2. History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy. 3. Pregnant or breast feeding. 4. Lesions involving the ampullary area. 5. Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3). 6. Scar of previous endoscopic procedures within 10mm around the lesion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 2 weeks | iIntraoperative and postoperative adverse events; through medical records and telephone follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant intra-procedural bleeding Intraoperative adverse events Delayed perforation | intra-procedural | Not responsive to water flushing and clips are needed |
| En bloc resection | intra-procedural | specimen resected in one piece |
| Procedure duration | intra-procedural | the entire duration of the procedure, not including ascending of the scope and looking for the lesions |
| Recurrence after 6 months | 6 months | confirmed by colonoscopy |
| Postoperative adverse events | 2 weeks | postoperative adverse events; through medical records and telephone follow up |
| Clinically significant delayed bleeding | 2 weeks | Leading to emergency room visit, readmission, or intervention |
| Delayed perforation | 2 weeks | Image confirmed |
| Intraoperative deep mural injury | intra-procedural | stage III/IV/V |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of clips | intra-procedural | number of clips used to close the wound |
| Number of treatment after technical failure | 6 months | through medical records and telephone follow up |
| Cost | 2 weeks | total cost of hospitalization |
Countries
China
Contacts
Primary ContactXin-Yang Liu, MD,MPH
Backup ContactQuan-Lin Li, MD,PhD
Outcome results
None listed