Esophageal Superficial Mucosal LesionNCT03404921
Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma
A study testing ESTD and ESD in people with Esophageal Superficial Mucosal Lesion, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
To evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Superficial Mucosal Lesion
- What is being tested?
- ESTD and ESD
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years;
- Biopsy confirmed early esophageal cancer and high-grade intraepithelial neoplasia (HGIN)which were eligible for conventional ESD indications;
- Suspected localized mucosal lesions detected by endoscopy.
Who cannot join
- Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator.
- The ASA classification of physical status ≥ 4 as judged by the investigator.
- Severe hepatic disease or renal disease
- Ability to understand and the willingness to sign a written informed consent document.
- Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator.
- Haemorrhagic disorder.
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- Patients who had a history of esophagectomy or a recurrent lesion.
- Planned treatment with: warfarin (including other vitamin K antagonists), cisapride,phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus,theophylline, lidocaine, nifedipine.
- Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
- Known or suspected alcohol, drug or medication abuse.
- Any condition associated with poor compliance as judged by the investigator.
- Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment.
- Involvement in the planning and conduct of the study. Previous enrollment in the present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma: a Prospective Multicenter Study
To evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma.
Read the detailed description
This multicenter, prospective, randomized, controlled study aims to evaluate the efficacy and safety of the tunnel technique in ESD of superficial esophageal squamous cell carcinoma (ESCC). Specifically the tunnel technique would be compared to conventional method on the procedure time and the muscular layer injury rate in patients scheduled for ESD with indication of ESCC.
- Conditions
- Esophageal Superficial Mucosal Lesion
- Being tested
- ESTD, ESD
- Keywords
- Endoscopic submucosal dissection, Endoscopic submucosal tunnelling dissection, procedure time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTDProcedure or surgery
During the ESTD procedure,after marking and submucosal injection, incisions were made at both the anal and oral sides of the lesion, and the submucosa under the lesion was then dissected to create a tunnel between the distal and proximal incisions. When the endscope reached the lower incision, the distal end of the esophageal lumen could be visualized , then two lateral mucosal incisions were made, thus completing the ESD procedure.
ESDProcedure or surgery
The ESD procedure involved marking,injection,circumferential cutting, submucosal dissection.
| Study group | Role | What they receive |
|---|---|---|
| ESTD group | Experimental | Use tunnelling method during ESD operation Receives: Procedure: ESTD |
| ESD group | Other | Use traditional method during ESD operation Receives: Procedure: ESD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The procedure time
Procedure time was defined as the time from marking of the lesion until complete removal of the specimen,including hemostasis.
Measured: day 1
Secondary outcomes (2)
The rate of bleeding during operation
The hemorrhage observed during the operation
Measured: day 1
The rate of injury to the muscular layer
The injury to the muscular layer observed during the operation
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Jan 2018
- Primary completion30 Jun 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Superficial Mucosal LesionStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Tongji Hospital, First Affiliated Hospital of Suzhou Medical College, Shanghai Zhongshan Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Principal investigator, Zhiguo Liu, Xijing Hospital of Digestive Diseases
- Investigators
- Zhiguo Liu, Principal investigator, Xijing Hospital of Digestive Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404921
- Sponsor's protocol ID
- KY20172066-1
- Status last verified
- Jul 2019
- First submitted
- 13 Jan 2018
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fan X, Wu Q, Li R, Chen W, Xie H, Zhao X, Zhu S, Fan C, Li J, Liu M, Liu Z, Han Y. Clinical benefit of tunnel endoscopic submucosal dissection for esophageal squamous cancer: a multicenter, randomized controlled trial. Gastrointest Endosc. 2022 Sep;96(3):436-444. doi: 10.1016/j.gie.2022.04.016. Epub 2022 Apr 22.
PubMed 35461890
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT03404921
- Acronym / sponsor ID
- KY20172066-1
- Conditions
- Esophageal Superficial Mucosal Lesion
- Keywords
- Endoscopic submucosal dissection, Endoscopic submucosal tunnelling dissection, procedure time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Tongji Hospital, First Affiliated Hospital of Suzhou Medical College, Shanghai Zhongshan Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 19 Jan 2018 (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.
To evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma.
Detailed description
This multicenter, prospective, randomized, controlled study aims to evaluate the efficacy and safety of the tunnel technique in ESD of superficial esophageal squamous cell carcinoma (ESCC). Specifically the tunnel technique would be compared to conventional method on the procedure time and the muscular layer injury rate in patients scheduled for ESD with indication of ESCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESTD group | Experimental | Procedure: ESTDUse tunnelling method during ESD operation |
| ESD group | Other | Procedure: ESDUse traditional method during ESD operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years;
- Biopsy confirmed early esophageal cancer and high-grade intraepithelial neoplasia (HGIN)which were eligible for conventional ESD indications;
- Suspected localized mucosal lesions detected by endoscopy.
Key exclusion criteria (13 listed)
- Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator.
- The ASA classification of physical status ≥ 4 as judged by the investigator.
- Severe hepatic disease or renal disease
- Ability to understand and the willingness to sign a written informed consent document.
- Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator.
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 |
|---|---|---|
| ESTDDuring the ESTD procedure,after marking and submucosal injection, incisions were made at both the anal and oral sides of the lesion, and the submucosa under the lesion was then dissected to create a tunnel between the distal and proximal incisions. When the endscope reached the lower incision, the distal end of the esophageal lumen could be visualized , then two lateral mucosal incisions were made, thus completing the ESD procedure. | Procedure or surgery | ESTD group |
| ESDThe ESD procedure involved marking,injection,circumferential cutting, submucosal dissection. | Procedure or surgery | ESD group |
Primary outcome
The procedure time
Time frame: day 1
Procedure time was defined as the time from marking of the lesion until complete removal of the specimen,including hemostasis.
2 secondary outcomes
The rate of bleeding during operation
Time frame: day 1
The rate of injury to the muscular layer
Time frame: day 1
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 17 Jul 2019.
- Derived from this study: PubMed 35461890Fan X, Wu Q, Li R, Chen W, Xie H, Zhao X, Zhu S, Fan C, Li J, Liu M, Liu Z, Han Y. Clinical benefit of tunnel endoscopic submucosal dissection for esophageal squamous cancer: a multicenter, randomized controlled trial. Gastrointest Endosc. 2022 Sep;96(3):436-444. doi: 10.1016/j.gie.2022.04.016. Epub 2022 Apr 22.
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.
Zhiguo Liu principal investigator
Xijing Hospital of Digestive Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESTD and ESD in people with Esophageal Superficial Mucosal Lesion, run by Xijing Hospital of Digestive Diseases 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 13 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 17 Jul 2019. 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?
The procedure time (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404921, which also lists 1 linked publication.
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 17 Jul 2019.