CSP vs EMR for >6mm Superficial Non-ampullary Duodenal Tumors

Shanghai Zhongshan Hospital183 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

183

Conditions

Duodenal Tumor

Interventions

Endoscopic resection: CSP/p-CSPPROCEDURE

Patients in the experimental arm will be assigned to receive CSP/p-CSP.

Endoscopic resection: EMR/EPMRPROCEDURE

Patients in the historical control arm have already finished EMR/EPMR

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Adverse events

iIntraoperative and postoperative adverse events; through medical records and telephone follow up

Time frame: 2 weeks

Secondary Outcomes

Postoperative adverse events

postoperative adverse events; through medical records and telephone follow up

Time frame: 2 weeks

Clinically significant delayed bleeding

Leading to emergency room visit, readmission, or intervention

Time frame: 2 weeks

Delayed perforation

Image confirmed

Time frame: 2 weeks

Clinically significant intra-procedural bleeding Intraoperative adverse events Delayed perforation

Not responsive to water flushing and clips are needed

Time frame: intra-procedural

Intraoperative deep mural injury

stage III/IV/V

Time frame: intra-procedural

En bloc resection

specimen resected in one piece

Time frame: intra-procedural

Procedure duration

the entire duration of the procedure, not including ascending of the scope and looking for the lesions

Time frame: intra-procedural

Recurrence after 6 months

Central Contacts

Xin-Yang Liu, MD,MPH

CONTACT

13661802849 liu.xinyang@zs-hospital.sh.cn

Quan-Lin Li, MD,PhD

CONTACT

13564671882 li.quanlin@zs-hospital.sh.cn

Data from ClinicalTrials.gov

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