Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma

An observational study of Esophageal Cancer, run by Changhai Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Endoscopic submucosal dissection (ESD) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (EESCC), The data of EESCC patients who received ESD or esophagectomy were retrospectively analyzed,The aim of this study was to compare the efficacy and safety of ESD and… Read more about this study

Who is it for?: Any age
Conditions the study is for: Esophageal Cancer
What is being tested?: Endoscopic submucosal dissection and Esophagectomy
Type of treatment: Surgery or procedure
How many people: 191 participants
Where: 1 siteChina
Study dates: 1 Jan 2011to 1 Jan 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with early esophageal cancer from January 2011 to January 2021 admitted to Changhai Hospital were included in this study.Patients treated with ESD were classified as the ESD group, and those who underwent radical esophageal cancer treatment were classified as the surgical group.

Who may be able to join

Mucosal or submucosal squamous cell carcinoma of the esophagus
no lymph node involvement or distant metastasis on computed tomography (CT) or pathology;

Who cannot join

Tis premalignant lesions (high-grade intraepithelial neoplasia;HGIN)
patients with neoadjuvant therapy
patients combined with severe diseases of other organs

Trial locations and contacts

1 site in 1 country.

China1 site

Changhai Hospital, Naval Medical University
Shanghai

Other trials in China

About this study

Official title: Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma：a Cohort Study

Read the detailed description

Endoscopic submucosal dissection (ESD) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (EESCC).The aim of this study was to compare the efficacy and safety of ESD and esophagectomy in EESCC，The data of EESCC patients who received ESD or esophagectomy were retrospectively analyzed. Overall survival (OS), disease specific survival (DSS), recurrence free survival (RFS), and procedure-related variables were compared between ESD and esophagectomy patients.Risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.

Conditions: Esophageal Cancer
Being tested: Endoscopic submucosal dissection, Esophagectomy
Medical subject headings: Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endoscopic submucosal dissectionProcedure or surgery
The patient was positioned in the left lateral decubitus position.Marking dots were made with a dual knife/hybrid knife around the lesion, and a solution of glycerin fructose with indigo carmine was injected into the submucosal layer to lift the lesion. Finally, after pre-cutting of the mucosal and submucosal layers around the lesion and dissection of the submucosa, the lesion was removed en bloc.
EsophagectomyProcedure or surgery
The main surgical methods of esophagectomy include the McKeown operation, Lvor-lewis, Sweet and minimally invasive radical resection of esophageal cancer (MIE)

Study groups in NCT06060106
Study group	Role	What they receive
Endoscopic submucosal dissection		Early esophageal cancer patients treated with ESD Receives: Procedure: Endoscopic submucosal dissection
Esophagectomy		Early esophageal cancer patients treated with esophagectomy Receives: Procedure: Esophagectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

overall survival (OS)
OS was measured from the date of ESD or esophagectomy until death from any cause
Measured: 10 years
Disease specific survival (DSS)
DSS was measured from the date of ESD or esophagectomy until death resulting from ESCC
Measured: 10 years
Recurrence free survival (RFS)
RFS was measured from the date of ESD or esophagectomy until the first recurrence or metastasis
Measured: 10 years

Secondary outcomes (5)

postoperative complications
Major postoperative complications includes bleeding, infection, and perforation，stricture and anastomotic leakage, adverse events assessed by blood tests, imageological examination and Endoscopic evaluation. Complications were graded according to the Clavien-Dindo classification system. The higher the complication grade, the more serious.
Measured: 30 days
R0 resection
R0 resection was defined as horizontal and vertical margins free from both cancerous and precancerous tissues (HGIN), and without evidence of LVI. Pathological assessment was performed independently by two pathologists.
Measured: 15 days
adjuvant therapy
During follow-up, record whether Adjuvant therapy (i.e., additional endoscopy/surgery, radiotherapy and/or chemotherapy) was administered.
Measured: 10 years
operation time
Time from start to finish of operation, measured in minutes
Measured: 12 hours
Post-operative hospitalization days
Date of discharge minus date of operation,measured in days
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20111 Jan 2023

First posted29 Sep 2023
Study start1 Jan 2011
Primary completion1 Jan 2021
Study completion1 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Esophageal CancerStudies of the same condition, open and under way.
More trials run by Changhai 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06060106
Sponsor's protocol ID: early esophageal carcinoma
Status last verified: Sep 2023
First submitted: 15 Jun 2023
Last updated: 29 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhang Y, Ding H, Chen T, Zhang X, Chen WF, Li Q, Yao L, Korrapati P, Jin XJ, Zhang YX, Xu MD, Zhou PH. Outcomes of Endoscopic Submucosal Dissection vs Esophagectomy for T1 Esophageal Squamous Cell Carcinoma in a Real-World Cohort. Clin Gastroenterol Hepatol. 2019 Jan;17(1):73-81.e3. doi: 10.1016/j.cgh.2018.04.038. Epub 2018 Apr 25.
PubMed 29704682
An W, Liu MY, Zhang J, Cui YP, Gao J, Wang LP, Chen Y, Yang LX, Chen HZ, Jin H, Liu F, Chen J, Li ZS, Wang LW, Shi XG, Sun C. Endoscopic submucosal dissection versus esophagectomy for early esophageal squamous cell carcinoma with tumor invasion to different depths. Am J Cancer Res. 2020 Sep 1;10(9):2977-2992. eCollection 2020.
PubMed 33042630
Liu Z, Zhao R. Endoscopic Submucosal Dissection vs. Surgery for Superficial Esophageal Squamous Cancer: A Systematic Review and Meta-Analysis. Front Oncol. 2022 Apr 21;12:816832. doi: 10.3389/fonc.2022.816832. eCollection 2022.
PubMed 35530330
Qian M, Feng S, Zhou H, Chen L, Wang S, Zhang K. Endoscopic submucosal dissection versus esophagectomy for t1 esophageal squamous cell carcinoma: a propensity score-matched analysis. Ther Adv Gastroenterol. 2022 Nov 21;15:17562848221138156. doi: 10.1177/17562848221138156. eCollection 2022.
PubMed 36458047

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Esophageal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma：a Cohort Study
ClinicalTrials.gov ID: NCT06060106
Acronym / sponsor ID: early esophageal carcinoma
Conditions: Esophageal Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Changhai HospitalUniversity, hospital or other
Study start: 1 Jan 2011 (actual)
Primary completion: 1 Jan 2021 (actual)
Study completion: 1 Jan 2023 (actual)
First posted: 29 Sep 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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Endoscopic submucosal dissection	–	Procedure: Endoscopic submucosal dissectionEarly esophageal cancer patients treated with ESD
Esophagectomy	–	Procedure: EsophagectomyEarly esophageal cancer patients treated with esophagectomy

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with early esophageal cancer from January 2011 to January 2021 admitted to Changhai Hospital were included in this study.Patients treated with ESD were classified as the ESD group, and those who underwent radical esophageal cancer treatment were classified as the surgical group.

Key inclusion criteria (2 listed)

Mucosal or submucosal squamous cell carcinoma of the esophagus
no lymph node involvement or distant metastasis on computed tomography (CT) or pathology;

Key exclusion criteria (3 listed)

Tis premalignant lesions (high-grade intraepithelial neoplasia;HGIN)
patients with neoadjuvant therapy
patients combined with severe diseases of other organs

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 submucosal dissectionThe patient was positioned in the left lateral decubitus position.Marking dots were made with a dual knife/hybrid knife around the lesion, and a solution of glycerin fructose with indigo carmine was injected into the submucosal layer to lift the lesion. Finally, after pre-cutting of the mucosal and submucosal layers around the lesion and dissection of the submucosa, the lesion was removed en bloc.	Procedure or surgery	Endoscopic submucosal dissection
EsophagectomyThe main surgical methods of esophagectomy include the McKeown operation, Lvor-lewis, Sweet and minimally invasive radical resection of esophageal cancer (MIE)	Procedure or surgery	Esophagectomy

Primary outcome

overall survival (OS)
Time frame: 10 years
OS was measured from the date of ESD or esophagectomy until death from any cause
Disease specific survival (DSS)
Time frame: 10 years
DSS was measured from the date of ESD or esophagectomy until death resulting from ESCC
Recurrence free survival (RFS)
Time frame: 10 years
RFS was measured from the date of ESD or esophagectomy until the first recurrence or metastasis

5 secondary outcomes

postoperative complications
Time frame: 30 days
R0 resection
Time frame: 15 days
adjuvant therapy
Time frame: 10 years
operation time
Time frame: 12 hours
Post-operative hospitalization days
Time frame: 30 days

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 29 Sep 2023.
Background: PubMed 29704682Zhang Y, Ding H, Chen T, Zhang X, Chen WF, Li Q, Yao L, Korrapati P, Jin XJ, Zhang YX, Xu MD, Zhou PH. Outcomes of Endoscopic Submucosal Dissection vs Esophagectomy for T1 Esophageal Squamous Cell Carcinoma in a Real-World Cohort. Clin Gastroenterol Hepatol. 2019 Jan;17(1):73-81.e3. doi: 10.1016/j.cgh.2018.04.038. Epub 2018 Apr 25.
Background: PubMed 33042630An W, Liu MY, Zhang J, Cui YP, Gao J, Wang LP, Chen Y, Yang LX, Chen HZ, Jin H, Liu F, Chen J, Li ZS, Wang LW, Shi XG, Sun C. Endoscopic submucosal dissection versus esophagectomy for early esophageal squamous cell carcinoma with tumor invasion to different depths. Am J Cancer Res. 2020 Sep 1;10(9):2977-2992. eCollection 2020.
Background: PubMed 35530330Liu Z, Zhao R. Endoscopic Submucosal Dissection vs. Surgery for Superficial Esophageal Squamous Cancer: A Systematic Review and Meta-Analysis. Front Oncol. 2022 Apr 21;12:816832. doi: 10.3389/fonc.2022.816832. eCollection 2022.
Background: PubMed 36458047Qian M, Feng S, Zhou H, Chen L, Wang S, Zhang K. Endoscopic submucosal dissection versus esophagectomy for t1 esophageal squamous cell carcinoma: a propensity score-matched analysis. Ther Adv Gastroenterol. 2022 Nov 21;15:17562848221138156. doi: 10.1177/17562848221138156. eCollection 2022.
Individual participant dataSharing planned: No

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RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
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Recruiting
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RecruitingObservational study
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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.

Wei An, Doctor principal investigator

Changhai Hospital

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 Esophageal Cancer, run by Changhai 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 2 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: finished, as of the sponsor's last update on 29 Sep 2023. 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?

overall survival (OS) (time frame: 10 years). The study lists 3 primary outcomes in all. 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 NCT06060106, which also lists 4 linked publications.

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 29 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.