Colorectal Endoscopic Submucosal Dissection(ESD) SurgeryNCT06076382
Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery
A study testing endoscopic ultrasound guided colorectal ESD surgery and the traditional colorectal ESD surgery in people with Colorectal Endoscopic Submucosal Dissection(ESD) Surgery, run by Jilin University at 1 site in China.
Trial summary
A prospective randomized controlled study protocol between endoscopic ultrasound guided colorectal ESD and traditional colorectal ESD surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Endoscopic Submucosal Dissection(ESD) Surgery
- What is being tested?
- endoscopic ultrasound guided colorectal ESD surgery and the traditional colorectal ESD surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2024to 30 Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases in our hospital who require colorectal ESD surgery
- Colorectal lesions（laterally spreading tumor）.
Who cannot join
- Laterally spreading tumor but not nodular mixed type(LST-G-M)
- Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment;
Trial locations and contacts
1 site in 1 country.
Dong Yang, doctor contact
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Changchun, Jilin, 130021
Dong Yang, Master
About this study
Official title: A Prospective Randomized Controlled Study Protocol Between Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery
A prospective randomized controlled study protocol between endoscopic ultrasound guided colorectal ESD and traditional colorectal ESD surgery
Read the detailed description
This study compare and analyze the efficiency of endoscopic ultrasound guided colorectal ESD surgery with traditional colorectal ESD surgery, in order to guide colorectal ESD operations.
- Being tested
- endoscopic ultrasound guided colorectal ESD surgery, the traditional colorectal ESD surgery
- Keywords
- colorectal, Endoscopic submucosal dissection, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ultrasound guided colorectal ESD surgeryProcedure or surgery
The experimental group first underwent endoscopic ultrasound examination, with a small ultrasound probe inserted into the intestinal cavity through the biopsy port. After water injection, the lesion was scanned and (1) the direction of gravity was determined. (2) fibrosis/infiltration under the mucosa, and the fibrosis was divided into F0 (no fibrosis), F1 (cold fibrosis), or F2 (severe fibrosis). (3) The lesion was divided into nine compartments. Mark submucosal fibrosis/infiltration sites, according to nine compartments. (4) Based on the results of endoscopic ultrasound scanning of the lesion, the surgeon draw up surgical approach and perform injection and dissection.
the traditional colorectal ESD surgeryProcedure or surgery
The control group underwent injection and dissection directly.
| Study group | Role | What they receive |
|---|---|---|
| the endoscopic ultrasound guided colorectal ESD surgery group | Experimental | The experimental group first underwent endoscopic ultrasound examination, with a small ultrasound probe inserted into the intestinal cavity through the biopsy port. Then undergo the colorectal ESD surgery. Receives: Procedure: endoscopic ultrasound guided colorectal ESD surgery |
| the traditional colorectal ESD surgery group | Active comparator | the traditional colorectal ESD surgery Receives: Procedure: the traditional colorectal ESD surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
operating time
from the injection to the end of dissection （minutes）
Measured: During surgery
Measure the area of the lesion
Measure the length and diameter of the lesion
Measured: During surgery
Secondary outcomes (3)
Number of propria muscle layer injuries during surgery
record the points of propria muscle layer injuries during surgery
Measured: During surgery
Time to first fluid diet
Postoperative recovery: record the first time of fluid diet
Measured: one week after surgery
Complete resection rate
record the number of complete resection cases
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start26 Mar 2024
- Primary completion28 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Endoscopic Submucosal Dissection(ESD) SurgeryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Yang, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076382
- Sponsor's protocol ID
- 130026
- Status last verified
- Apr 2024
- First submitted
- 24 Sep 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study Protocol Between Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery
- ClinicalTrials.gov ID
- NCT06076382
- Acronym / sponsor ID
- 130026
- Keywords
- colorectal, Endoscopic submucosal dissection, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 28 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 10 Oct 2023 (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.
A prospective randomized controlled study protocol between endoscopic ultrasound guided colorectal ESD and traditional colorectal ESD surgery
Detailed description
This study compare and analyze the efficiency of endoscopic ultrasound guided colorectal ESD surgery with traditional colorectal ESD surgery, in order to guide colorectal ESD operations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the endoscopic ultrasound guided colorectal ESD surgery group | Experimental | Procedure: endoscopic ultrasound guided colorectal ESD surgeryThe experimental group first underwent endoscopic ultrasound examination, with a small ultrasound probe inserted into the intestinal cavity through the biopsy port. Then undergo the colorectal ESD surgery. |
| the traditional colorectal ESD surgery group | Active comparator | Procedure: the traditional colorectal ESD surgerythe traditional colorectal ESD surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cases in our hospital who require colorectal ESD surgery
- Colorectal lesions（laterally spreading tumor）.
Key exclusion criteria (2 listed)
- Laterally spreading tumor but not nodular mixed type(LST-G-M)
- Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment;
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 ultrasound guided colorectal ESD surgeryThe experimental group first underwent endoscopic ultrasound examination, with a small ultrasound probe inserted into the intestinal cavity through the biopsy port. After water injection, the lesion was scanned and (1) the direction of gravity was determined. (2) fibrosis/infiltration under the mucosa, and the fibrosis was divided into F0 (no fibrosis), F1 (cold fibrosis), or F2 (severe fibrosis). (3) The lesion was divided into nine compartments. Mark submucosal fibrosis/infiltration sites, according to nine compartments. (4) Based on the results of endoscopic ultrasound scanning of the lesion, the surgeon draw up surgical approach and perform injection and dissection. | Procedure or surgery | the endoscopic ultrasound guided colorectal ESD surgery group |
| the traditional colorectal ESD surgeryThe control group underwent injection and dissection directly. | Procedure or surgery | the traditional colorectal ESD surgery group |
Primary outcome
operating time
Time frame: During surgery
from the injection to the end of dissection （minutes）
Measure the area of the lesion
Time frame: During surgery
Measure the length and diameter of the lesion
3 secondary outcomes
Number of propria muscle layer injuries during surgery
Time frame: During surgery
Time to first fluid diet
Time frame: one week after surgery
Complete resection rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- 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.
Dong Yang, doctor contact
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 ultrasound guided colorectal ESD surgery and the traditional colorectal ESD surgery in people with Colorectal Endoscopic Submucosal Dissection(ESD) Surgery, run by Jilin University 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 2 inclusion and 2 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 12 Apr 2024. 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 Hong Xu, professor (18844097668, 18844097668@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operating time (time frame: During surgery). The study lists 2 primary outcomes in all. 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 12 Apr 2024.