To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LSTLSTNCT06464874
Endoscopic Therapy for Laterally Spreading Tumors (LSTs)
An observational study of To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LST, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study will retrospectively include LST patients who were admitted to 6 medical centers (The Second Affiliated Hospital, College of Medicine, Zhejiang University; The Affiliated Jinhua Hospital, Zhejiang University School of Medicine; First Affiliated Hospital of Huzhou University; The Second Hospital of Jiaxing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LST
- What is being tested?
- Conventional ESD and Hybrid ESD
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 890 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 30 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study involved a multicenter retrospective analysis of 890 consecutive patients with a colorectal LST > 10 millimeters who underwent endoscopic treatment at 6 medical centers (The Second Affiliated Hospital, College of Medicine, Zhejiang University; The Affiliated Jinhua Hospital, Zhejiang University School of Medicine; First Affiliated Hospital of Huzhou University; The Second Hospital of Jiaxing; Jinhua People's Hospital; Lanxi People's Hospital) between May 2020 and April 2023.
Who may be able to join
- Age ≥18 years old;
- LST lesion diameter >1cm;
- Medical record data integrity
Who cannot join
- Pedicle lesions;
- Resection of residual lesions after endoscopic treatment;
- Advanced endoscopic imaging showed submucosal infiltrating lesions.
- The lesions are in patients with inflammatory bowel disease;
- Familial polyposis;
- Electrolyte abnormalities;
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- Coagulation dysfunction;
- Pregnant or lactating patients;
- Taking nonsteroidal anti-inflammatory drugs or anticoagulants;
- A history of alcoholism;
- Severe organ failure;
- Medical records are incomplete
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
About this study
Official title: Hybrid Versus Conventional Endoscopic Submucosal Dissection for Laterally Spreading Tumors (LSTs): A Retrospective Multicenter Study
This study will retrospectively include LST patients who were admitted to 6 medical centers (The Second Affiliated Hospital, College of Medicine, Zhejiang University; The Affiliated Jinhua Hospital, Zhejiang University School of Medicine; First Affiliated Hospital of Huzhou University; The Second Hospital of Jiaxing; Jinhua People's Hospital; Lanxi People's Hospital) from 2020.05.01 to 2023.04.30 with the purpose of comparing the efficacy and safety of hybrid ESD and ESD in the treatment of colorectal LST. The complete resection rate, operation time, operation cost, intraoperative and postoperative complications of hybrid ESD and ESD LST will be compared. To provide strong evidence for the selection of endoscopic treatment strategies for LST.
- Conditions
- To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LST
- Being tested
- Conventional ESD, Hybrid ESD
- Keywords
- Colorectal adenoma；Laterally spreading tumors, Endoscopic submucosal dissection, Hybrid endoscopic submucosal dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional ESDProcedure or surgery
Conventional ESD is the most suitable method for total resection, especially for large lesions. This method can complete the resection of early gastrointestinal cancer and precancerous lesions, while maintaining the integrity of digestive tract anatomy and physiological function.The operation difficulty of this technique is high, the equipment requirements are high, the operation time is long, and the complication rate is closely related to the technical level of the operator.
Hybrid ESDProcedure or surgery
Hybrid ESD is a better choice, but only can remove the lesion in one piece, but also has a lower technical difficulty than conventional ESD
| Study group | Role | What they receive |
|---|---|---|
| conventional ESD | Submucosal injection of methylene blue solution at various sites was performed, followed by periphery incision using a dual knife. The submucosal injection was administered multiple times, followed by the utilization of an IT knife for submucosal separation and gradual excision of the lesion. In cases of significant bleeding at the wound site, electrocoagulation hemostatic forceps were employed for hemostasis. Receives: Procedure: Conventional ESD | |
| hybrid ESD | The submucosal injection and circumferential incision of the Hybrid ESD were performed as described above. Subsequently, snaring was conducted post submucosal dissection utilizing a polypectomy snare for complete lesion removal. Careful attention was paid during excision to avoid muscle layer penetration and to control cutting speed in order to mitigate the potential for hemorrhage and perforation. The subsequent steps of the procedure closely followed the conventional ESD methodology outlined previously. Receives: Procedure: Hybrid ESD |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete resection rate
One-time complete excision
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 May 2020
- Primary completion30 Apr 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LSTStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 890 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464874
- Sponsor's protocol ID
- 2023-0444
- Acronym
- LST
- Status last verified
- May 2020
- First submitted
- 13 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Versus Conventional Endoscopic Submucosal Dissection for Laterally Spreading Tumors (LSTs): A Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06464874
- Acronym / sponsor ID
- LST / 2023-0444
- Conditions
- To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LST
- Keywords
- Colorectal adenoma；Laterally spreading tumors, Endoscopic submucosal dissection, Hybrid endoscopic submucosal dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 18 Jun 2024 (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.
This study will retrospectively include LST patients who were admitted to 6 medical centers (The Second Affiliated Hospital, College of Medicine, Zhejiang University; The Affiliated Jinhua Hospital, Zhejiang University School of Medicine; First Affiliated Hospital of Huzhou University; The Second Hospital of Jiaxing; Jinhua People's Hospital; Lanxi People's Hospital) from 2020.05.01 to 2023.04.30 with the purpose of comparing the efficacy and safety of hybrid ESD and ESD in the treatment of colorectal LST. The complete resection rate, operation time, operation cost, intraoperative and postoperative complications of hybrid ESD and ESD LST will be compared. To provide strong evidence for the selection of endoscopic treatment strategies for LST.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional ESD | – | Procedure: Conventional ESDSubmucosal injection of methylene blue solution at various sites was performed, followed by periphery incision using a dual knife. The submucosal injection was administered multiple times, followed by the utilization of an IT knife for submucosal separation and gradual excision of the lesion. In cases of significant bleeding at the wound site, electrocoagulation hemostatic forceps were employed for hemostasis. |
| hybrid ESD | – | Procedure: Hybrid ESDThe submucosal injection and circumferential incision of the Hybrid ESD were performed as described above. Subsequently, snaring was conducted post submucosal dissection utilizing a polypectomy snare for complete lesion removal. Careful attention was paid during excision to avoid muscle layer penetration and to control cutting speed in order to mitigate the potential for hemorrhage and perforation. The subsequent steps of the procedure closely followed the conventional ESD methodology outlined previously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study involved a multicenter retrospective analysis of 890 consecutive patients with a colorectal LST > 10 millimeters who underwent endoscopic treatment at 6 medical centers (The Second Affiliated Hospital, College of Medicine, Zhejiang University; The Affiliated Jinhua Hospital, Zhejiang University School of Medicine; First Affiliated Hospital of Huzhou University; The Second Hospital of Jiaxing; Jinhua People's Hospital; Lanxi People's Hospital) between May 2020 and April 2023.
Key inclusion criteria (3 listed)
- Age ≥18 years old;
- LST lesion diameter >1cm;
- Medical record data integrity
Key exclusion criteria (12 listed)
- Pedicle lesions;
- Resection of residual lesions after endoscopic treatment;
- Advanced endoscopic imaging showed submucosal infiltrating lesions.
- The lesions are in patients with inflammatory bowel disease;
- Familial polyposis;
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 |
|---|---|---|
| Conventional ESDConventional ESD is the most suitable method for total resection, especially for large lesions. This method can complete the resection of early gastrointestinal cancer and precancerous lesions, while maintaining the integrity of digestive tract anatomy and physiological function.The operation difficulty of this technique is high, the equipment requirements are high, the operation time is long, and the complication rate is closely related to the technical level of the operator. | Procedure or surgery | conventional ESD |
| Hybrid ESDHybrid ESD is a better choice, but only can remove the lesion in one piece, but also has a lower technical difficulty than conventional ESD | Procedure or surgery | hybrid ESD |
Primary outcome
complete resection rate
Time frame: 2 weeks
One-time complete excision
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LST, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 18 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete resection rate (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 18 Jun 2024.