CSP vs EMR for >6mm Superficial Non-ampullary Duodenal Tumors
NCT ID: NCT05428553
Last Updated: 2022-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
183 participants
INTERVENTIONAL
2022-06-01
2023-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CSP/p-CSP
Prospective allocation
Endoscopic resection: CSP/p-CSP
Patients in the experimental arm will be assigned to receive CSP/p-CSP.
EMR/EPMR
Historical control
Endoscopic resection: EMR/EPMR
Patients in the historical control arm have already finished EMR/EPMR
Interventions
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Endoscopic resection: CSP/p-CSP
Patients in the experimental arm will be assigned to receive CSP/p-CSP.
Endoscopic resection: EMR/EPMR
Patients in the historical control arm have already finished EMR/EPMR
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Ping-Hong Zhou, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ShanghaiZhongshanEndoscopy1
Identifier Type: -
Identifier Source: org_study_id
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