Duodenal TumorCSP; EMRNCT05428553
CSP vs EMR for >6mm Superficial Non-ampullary Duodenal Tumors
A study testing Endoscopic resection: CSP/p-CSP and Endoscopic resection: EMR/EPMR in people with Duodenal Tumor, run by Shanghai Zhongshan Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Duodenal Tumor
- What is being tested?
- Endoscopic resection: CSP/p-CSP and Endoscopic resection: EMR/EPMR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experimental arm: CSP/p-CSP
- Patients of age 18-75 years.
- Lesion located in the duodenum.
- Superficial non-ampullary duodenal tumors (SNADTs) (>6mm, Sessile).
- Written informed consent.
- Benign adenomatous surface features (Kudo III / IV, JNET(Japan NBI (narrow-band imaging) Expert Team) 2a).
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- Control arm: EMR/EPMR
- Patients of age 18-75 years.
- Lesion located in the duodenum.
- Superficial non-ampullary duodenal tumors (SNADTs) (>6mm, Sessile).
- Benign adenomatous surface features (Kudo III / IV, JNET 2a).
- Received EMR/EPMR already.
- Provided written informed consent for use of clinical information.
Who cannot join
- Experimental arm: CSP/p-CSP
- 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.
- History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy at the time of EMR/EPMR.
- Pregnant or breast feeding at the time of EMR/EPMR.
- Lesions involving the ampullary area.
- Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3).
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- Scar of previous endoscopic procedures within 10mm around the lesion.
- Control arm: EMR/EPMR
- 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)；.
- History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy.
- Pregnant or breast feeding.
- Lesions involving the ampullary area.
- Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3).
- Scar of previous endoscopic procedures within 10mm around the lesion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Xin-Yang Liu, MD,MPH, 86-13661802849, shmulxy@163.com
Ping-Hong Zhou, MD,FASGE
About this study
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
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).
Read the 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).
- Conditions
- Duodenal Tumor
- Being tested
- Endoscopic resection: CSP/p-CSP, Endoscopic resection: EMR/EPMR
- Medical subject headings
- Duodenal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic resection: CSP/p-CSPProcedure or surgery
Patients in the experimental arm will be assigned to receive CSP/p-CSP.
Endoscopic resection: EMR/EPMRProcedure or surgery
Patients in the historical control arm have already finished EMR/EPMR
| Study group | Role | What they receive |
|---|---|---|
| CSP/p-CSP | Experimental | Prospective allocation Receives: Procedure: Endoscopic resection: CSP/p-CSP |
| EMR/EPMR | Active comparator | Historical control Receives: Procedure: Endoscopic resection: EMR/EPMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
iIntraoperative and postoperative adverse events; through medical records and telephone follow up
Measured: 2 weeks
Secondary outcomes (8)
Postoperative adverse events
postoperative adverse events; through medical records and telephone follow up
Measured: 2 weeks
Clinically significant delayed bleeding
Leading to emergency room visit, readmission, or intervention
Measured: 2 weeks
Delayed perforation
Image confirmed
Measured: 2 weeks
Clinically significant intra-procedural bleeding Intraoperative adverse events Delayed perforation
Not responsive to water flushing and clips are needed
Measured: intra-procedural
Intraoperative deep mural injury
stage III/IV/V
Measured: intra-procedural
En bloc resection
specimen resected in one piece
Measured: intra-procedural
Procedure duration
the entire duration of the procedure, not including ascending of the scope and looking for the lesions
Measured: intra-procedural
Recurrence after 6 months
confirmed by colonoscopy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Jun 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal TumorStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping-Hong Zhou, MD,PhD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428553
- Sponsor's protocol ID
- ShanghaiZhongshanEndoscopy1
- Acronym
- CSP; EMR
- Status last verified
- Mar 2022
- First submitted
- 20 Mar 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Original data could be shared at request by email after publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05428553
- Acronym / sponsor ID
- CSP; EMR / ShanghaiZhongshanEndoscopy1
- Conditions
- Duodenal Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSP/p-CSP | Experimental | Procedure: Endoscopic resection: CSP/p-CSPProspective allocation |
| EMR/EPMR | Active comparator | Procedure: Endoscopic resection: EMR/EPMRHistorical control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Experimental arm: CSP/p-CSP
- Patients of age 18-75 years.
- Lesion located in the duodenum.
- Superficial non-ampullary duodenal tumors (SNADTs) (>6mm, Sessile).
- Written informed consent.
Key exclusion criteria (14 listed)
- Experimental arm: CSP/p-CSP
- 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.
- History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy at the time of EMR/EPMR.
- Pregnant or breast feeding at the time of EMR/EPMR.
- Lesions involving the ampullary area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic resection: CSP/p-CSPPatients in the experimental arm will be assigned to receive CSP/p-CSP. | Procedure or surgery | CSP/p-CSP |
| Endoscopic resection: EMR/EPMRPatients in the historical control arm have already finished EMR/EPMR | Procedure or surgery | EMR/EPMR |
Primary outcome
Adverse events
Time frame: 2 weeks
iIntraoperative and postoperative adverse events; through medical records and telephone follow up
8 secondary outcomes
Postoperative adverse events
Time frame: 2 weeks
Clinically significant delayed bleeding
Time frame: 2 weeks
Delayed perforation
Time frame: 2 weeks
Clinically significant intra-procedural bleeding Intraoperative adverse events Delayed perforation
Time frame: intra-procedural
Intraoperative deep mural injury
Time frame: intra-procedural
En bloc resection
Time frame: intra-procedural
Procedure duration
Time frame: intra-procedural
Recurrence after 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: Yes. Original data could be shared at request by email after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-Hong Zhou, MD,PhD principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic resection: CSP/p-CSP and Endoscopic resection: EMR/EPMR in people with Duodenal Tumor, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin-Yang Liu, MD,MPH (13661802849, liu.xinyang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.