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

Duodenal Tumor Clinical Trial

— CSP; EMR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05428553
• Other study ID #: ShanghaiZhongshanEndoscopy1
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Xin-Yang Liu, MD,MPH
• Phone: 13661802849
• Email: liu.xinyang[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 183
• Est. completion date: November 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Duodenal Neoplasms
• Duodenal Tumor

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost	total cost of hospitalization	2 weeks
Other	Number of treatment after technical failure	through medical records and telephone follow up	6 months
Other	Number of clips	number of clips used to close the wound	intra-procedural
Primary	Adverse events	iIntraoperative and postoperative adverse events; through medical records and telephone follow up	2 weeks
Secondary	Postoperative adverse events	postoperative adverse events; through medical records and telephone follow up	2 weeks
Secondary	Clinically significant delayed bleeding	Leading to emergency room visit, readmission, or intervention	2 weeks
Secondary	Delayed perforation	Image confirmed	2 weeks
Secondary	Clinically significant intra-procedural bleeding Intraoperative adverse events Delayed perforation	Not responsive to water flushing and clips are needed	intra-procedural
Secondary	Intraoperative deep mural injury	stage III/IV/V	intra-procedural
Secondary	En bloc resection	specimen resected in one piece	intra-procedural
Secondary	Procedure duration	the entire duration of the procedure, not including ascending of the scope and looking for the lesions	intra-procedural
Secondary	Recurrence after 6 months	confirmed by colonoscopy	6 months