Colorectal NeoplasmsNCT05045911
An Endoscopic Barbed-clips Suturing for Colorectal ESD
A study testing Endoscopic Barbed-clips Suturing in people with Colorectal Neoplasms, run by Affiliated Hospital to Academy of Military Medical Sciences at 2 sites in China.
Trial summary
Endoscopic submucosal dissection (ESD) was developed to allow en bloc resection of colorectal neoplasm. Although colorectal ESD has been widely accepted as a minimally invasive treatment option for early colorectal neoplasm, post-ESD bleeding is one of the major adverse events. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Endoscopic Barbed-clips Suturing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesChina
- Study dates
- 20 Sep 2021to 20 Dec 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged≥20 years with a single clinically or histologically diagnosed colorectal lesions of 20-50mm eligible for which fulfilled criteria for ESD;
Who cannot join
- Patients with coagulopathy (platelet count < 5 × 10*4, prothrombin time international normalized ratio > 2,
- medical conditions requiring the continuous use of antithrombotic agents
- prior abdominal surgery or radiation.
Trial locations and contacts
2 sites in 1 country.
Pei Deng, Dr. contact
China2 sites, 2 recruiting
- Recruiting
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100071
Min Min, Dr., +8613426165452, minmin823@sina.com
Yan Liu, Pro.
- Recruiting
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Yan Liu, +8613911798288, 13911798288@163.com
Yan Liu
About this study
Official title: A Novel Endoscopic Barbed-clips Suturing for Mucosal Defect Closure After Endoscopic Submucosal Dissection of Colon
Endoscopic submucosal dissection (ESD) was developed to allow en bloc resection of colorectal neoplasm. Although colorectal ESD has been widely accepted as a minimally invasive treatment option for early colorectal neoplasm, post-ESD bleeding is one of the major adverse events. After ESD procedure, endoscopists close the defects with devices to prevent complications. A novel endoscopic barbed-clips suturing has been developed to simplify endoscopic closure. In this study, the endoscopic barbed-clips will be evaluated when closing defects in the colon after ESD.
Read the detailed description
Endoscopic submucosal dissection (ESD) has emerged as a new endoscopic technique that allows en-bloc resection of GI lesions, irrespective of size. The most common complications of the ESD techniques are bleeding and perforation. Several reports have shown that if prophylactic closure of a mucosal defect with clips would reduce the risk of bleeding following endoscopic intervention by ESD. With the advancements in endoscopic therapy, various techniques for prevention of post-ESD complications have been reported. However, there have some limitations including their inability to close large defects and the complexity of the approaches and the need for expensive equipment to complete the procedure. To address these issues, we have devised a novel endoscopic barbed-clips suturing method for mucosal defect closure after endoscopic submucosal dissection of colon. In this study, we assessed the technical feasibility of this novel technique.
- Conditions
- Colorectal Neoplasms
- Being tested
- Endoscopic Barbed-clips Suturing
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Barbed-clips SuturingProcedure or surgery
Endoscopic Barbed-clips Suturing
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Barbed-clips Suturing | Experimental | Patients will be closed the mucosal defect after colorectal ESD using Endoscopic Barbed-clips Suturing. Receives: Procedure: Endoscopic Barbed-clips Suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The technical success rate
Rate of completely closure of the ESD defect
Measured: 1 day
Secondary outcomes (3)
Endoscopic barbed-clips suturing closure time
The time required to close the defect using endoscopic barbed-clips suturing
Measured: 1 day
Rate of patients reported with bleeding/perforation post-ESD procedure
Conduct follow-ups for risk of bleeding and perforation after closure
Measured: 7 days
Clips used post-ESD
Record number of clips needed to close lesion
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start20 Sep 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045911
- Sponsor's protocol ID
- Endo-barbed clips suturing
- Status last verified
- Sep 2021
- First submitted
- 17 Aug 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Endoscopic Barbed-clips Suturing for Mucosal Defect Closure After Endoscopic Submucosal Dissection of Colon
- ClinicalTrials.gov ID
- NCT05045911
- Acronym / sponsor ID
- Endo-barbed clips suturing
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 16 Sep 2021 (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.
Endoscopic submucosal dissection (ESD) was developed to allow en bloc resection of colorectal neoplasm. Although colorectal ESD has been widely accepted as a minimally invasive treatment option for early colorectal neoplasm, post-ESD bleeding is one of the major adverse events. After ESD procedure, endoscopists close the defects with devices to prevent complications. A novel endoscopic barbed-clips suturing has been developed to simplify endoscopic closure. In this study, the endoscopic barbed-clips will be evaluated when closing defects in the colon after ESD.
Detailed description
Endoscopic submucosal dissection (ESD) has emerged as a new endoscopic technique that allows en-bloc resection of GI lesions, irrespective of size. The most common complications of the ESD techniques are bleeding and perforation. Several reports have shown that if prophylactic closure of a mucosal defect with clips would reduce the risk of bleeding following endoscopic intervention by ESD. With the advancements in endoscopic therapy, various techniques for prevention of post-ESD complications have been reported. However, there have some limitations including their inability to close large defects and the complexity of the approaches and the need for expensive equipment to complete the procedure. To address these issues, we have devised a novel endoscopic barbed-clips suturing method for mucosal defect closure after endoscopic submucosal dissection of colon. In this study, we assessed the technical feasibility of this novel technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Barbed-clips Suturing | Experimental | Procedure: Endoscopic Barbed-clips SuturingPatients will be closed the mucosal defect after colorectal ESD using Endoscopic Barbed-clips Suturing. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged≥20 years with a single clinically or histologically diagnosed colorectal lesions of 20-50mm eligible for which fulfilled criteria for ESD;
Key exclusion criteria (3 listed)
- Patients with coagulopathy (platelet count < 5 × 10*4, prothrombin time international normalized ratio > 2,
- medical conditions requiring the continuous use of antithrombotic agents
- prior abdominal surgery or radiation.
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 Barbed-clips SuturingEndoscopic Barbed-clips Suturing | Procedure or surgery | Endoscopic Barbed-clips Suturing |
Primary outcome
The technical success rate
Time frame: 1 day
Rate of completely closure of the ESD defect
3 secondary outcomes
Endoscopic barbed-clips suturing closure time
Time frame: 1 day
Rate of patients reported with bleeding/perforation post-ESD procedure
Time frame: 7 days
Clips used post-ESD
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Pei Deng, Dr. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Barbed-clips Suturing in people with Colorectal Neoplasms, run by Affiliated Hospital to Academy of Military Medical Sciences at 2 sites 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 1 inclusion and 3 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yiliang Bi, Dr. (+8613240439961, yiliangbi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The technical success rate (time frame: 1 day). 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 16 Sep 2021.