Clinical trial NCT05428553: CSP vs EMR for >6mm Superficial Non-ampullary Duodenal Tumors
Official title: Endoscopic Cold Snare Polypectomy Versus Endoscopic Mucosal Resection of Superficial Non-ampullary Duodenal Tumors (SNADTs) (>6mm, Sessile) - A Prospective Multicenter Historically Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Duodenal Tumor
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events
timeFrame: 2 weeks
Secondary outcomes:
measure: Postoperative adverse events
timeFrame: 2 weeks
measure: Clinically significant delayed bleeding
timeFrame: 2 weeks
measure: Delayed perforation
timeFrame: 2 weeks
measure: Clinically significant intra-procedural bleeding Intraoperative adverse events Delayed perforation
timeFrame: intra-procedural
measure: Intraoperative deep mural injury
timeFrame: intra-procedural
measure: En bloc resection
timeFrame: intra-procedural
measure: Procedure duration
timeFrame: intra-procedural
measure: Recurrence after 6 months
timeFrame: 6 months
Other outcomes:
measure: Cost
timeFrame: 2 weeks
measure: Number of treatment after technical failure
timeFrame: 6 months
measure: Number of clips
timeFrame: intra-procedural
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Ping-Hong Zhou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: