Esophageal CancerNCT06979986
SLND Versus Non-Dissection Following ESD for T1a Stage Esophageal Squamous Cell Carcinoma
A study testing Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection and Endoscopic Submucosal Dissection without SLND in people with Esophageal Cancer, run by Fujian Cancer Hospital.
Trial summary
This is a study from Fujian Cancer Hospital Thoracic of Surgery Project, numbered as FJCHTOSP-1. Systematically mediastinal Lymph Node Dissection (SLD) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma: a single-center, prospective clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection and Endoscopic Submucosal Dissection without SLND
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical stage T1aN0M0.
- A lesion detected on Endoscopic Ultrasound featured as T1a stage.
- Age 18 to 75.
- Patients who have signed the informed consent form.
Who cannot join
- • Other than invasive adenocarcinoma by pathological analysis.
- Not complete resected or curative intent.
- Patients who have history of other malignant tumors.
- Patients who have history of thoracic surgery.
- Patients who have received radiation, chemotherapy or other treatments previously.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Systematically Mediastinal Lymph Node Dissection (SLND) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma
This is a study from Fujian Cancer Hospital Thoracic of Surgery Project, numbered as FJCHTOSP-1. Systematically mediastinal Lymph Node Dissection (SLD) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma: a single-center, prospective clinical trial.
Read the detailed description
Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepared random tables. Participants in the systematically mediastinal lymph node dissection (SLND) group will receive systematically mediastinal lymph node dissection, while those in the non-SLND group will not receive mediastinal lymph node dissection. The primary endpoint is 3-year disease-free survival (DFS).
The sample size are estimated with reference to investigators' previous data, in which the 3-year DFS was 62.7% for patients diagnosed with T1a Stage Esophageal Squamous Cell Carcinoma and underwent Endoscopic Submucosal Dissection without SLND. Investigators assumed that if 3-year DFS of patients in SLND group was over 80%, then investigatorswould deem the SLND group to be superior to the non-SLND group. The sample size are estimated to be 102. Therefore, the total number of patients enrolled are designed to be 102.
- Conditions
- Esophageal Cancer
- Being tested
- Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection, Endoscopic Submucosal Dissection without SLND
- 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 Dissection with Systematically mediastinal Lymph Node DissectionProcedure or surgery
Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepared random tables. Participants in the SLND group will receive Endoscopic Submucosal Dissection with systematically mediastinal lymph node dissection
Endoscopic Submucosal Dissection without SLNDProcedure or surgery
Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepare random tables. Participants in the non-SLND group will just receive Endoscopic Submucosal Dissection treatment, not undergo Systematically mediastinal Lymph Node Dissection.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection | Experimental | T1a Stage Esophageal Squamous Cell Carcinoma undergo Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection Receives: Procedure: Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection |
| Endoscopic Submucosal Dissection without Systematically mediastinal Lymph Node Dissection | Placebo comparator | T1a Stage Esophageal Squamous Cell Carcinoma just recieve Endoscopic Submucosal Dissection treatment, not undergo Systematically mediastinal Lymph Node Dissection Receives: Procedure: Endoscopic Submucosal Dissection without SLND |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
disease-free survival
Measured: From enrollment to the end of treatment at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)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 Fujian Cancer 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Weimin Fang, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979986
- Sponsor's protocol ID
- FJCHTOSP-1
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared due to privacy regulations and restrictions stipulated by the ethics committee approval. Research participants were not informed during the consent process that their data might be widely shared. Additionally, this trial involves sensitive medical information that carries potential re-identification risks even after de-identification procedures. However, researchers interested in specific analyses are welcome to discuss potential collaboration through appropriate data use agreements.
Publications
Nishihira T, Hirayama K, Mori S. A prospective randomized trial of extended cervical and superior mediastinal lymphadenectomy for carcinoma of the thoracic esophagus. Am J Surg. 1998 Jan;175(1):47-51. doi: 10.1016/s0002-9610(97)00227-4.
PubMed 9445239Altorki N, Kent M, Ferrara C, Port J. Three-field lymph node dissection for squamous cell and adenocarcinoma of the esophagus. Ann Surg. 2002 Aug;236(2):177-83. doi: 10.1097/00000658-200208000-00005.
PubMed 12170022Tong DK, Law S, Kwong DL, Chan KW, Lam AK, Wong KH. Histological regression of squamous esophageal carcinoma assessed by percentage of residual viable cells after neoadjuvant chemoradiation is an important prognostic factor. Ann Surg Oncol. 2010 Aug;17(8):2184-92. doi: 10.1245/s10434-010-0995-2. Epub 2010 Mar 9.
PubMed 20217248Tachibana M, Kinugasa S, Yoshimura H, Dhar DK, Nagasue N. Extended esophagectomy with 3-field lymph node dissection for esophageal cancer. Arch Surg. 2003 Dec;138(12):1383-9; discussion 1390. doi: 10.1001/archsurg.138.12.1383.
PubMed 14662544Ando N, Ozawa S, Kitagawa Y, Shinozawa Y, Kitajima M. Improvement in the results of surgical treatment of advanced squamous esophageal carcinoma during 15 consecutive years. Ann Surg. 2000 Aug;232(2):225-32. doi: 10.1097/00000658-200008000-00013.
PubMed 10903602Hsu PK, Huang CS, Wang BY, Wu YC, Hsu WH. Survival benefits of postoperative chemoradiation for lymph node-positive esophageal squamous cell carcinoma. Ann Thorac Surg. 2014 May;97(5):1734-41. doi: 10.1016/j.athoracsur.2013.12.041. Epub 2014 Mar 6.
PubMed 24612702Hsu PK, Wang BY, Huang CS, Wu YC, Hsu WH. Prognostic factors for post-recurrence survival in esophageal squamous cell carcinoma patients with recurrence after resection. J Gastrointest Surg. 2011 Apr;15(4):558-65. doi: 10.1007/s11605-011-1458-1. Epub 2011 Feb 15.
PubMed 21327531Merkow RP, Bilimoria KY, Keswani RN, Chung J, Sherman KL, Knab LM, Posner MC, Bentrem DJ. Treatment trends, risk of lymph node metastasis, and outcomes for localized esophageal cancer. J Natl Cancer Inst. 2014 Jul 16;106(7):dju133. doi: 10.1093/jnci/dju133. Print 2014 Jul.
PubMed 25031273Chen J, Wu S, Zheng X, Pan J, Zhu K, Chen Y, Li J, Liao L, Lin Y, Liao Z. Cervical lymph node metastasis classified as regional nodal staging in thoracic esophageal squamous cell carcinoma after radical esophagectomy and three-field lymph node dissection. BMC Surg. 2014 Dec 19;14:110. doi: 10.1186/1471-2482-14-110.
PubMed 25527100Li H, Yang S, Zhang Y, Xiang J, Chen H. Thoracic recurrent laryngeal lymph node metastases predict cervical node metastases and benefit from three-field dissection in selected patients with thoracic esophageal squamous cell carcinoma. J Surg Oncol. 2012 May;105(6):548-52. doi: 10.1002/jso.22148. Epub 2011 Nov 21.
PubMed 22105736Tachibana M, Kinugasa S, Yoshimura H, Shibakita M, Tonomoto Y, Dhar DK, Nagasue N. Clinical outcomes of extended esophagectomy with three-field lymph node dissection for esophageal squamous cell carcinoma. Am J Surg. 2005 Jan;189(1):98-109. doi: 10.1016/j.amjsurg.2004.10.001.
PubMed 15701501Tabira Y, Kitamura N, Yoshioka M, Tanaka M, Nakano K, Toyota N, Mori T. Significance of three-field lymphadenectomy for carcinoma of the thoracic esophagus based on depth of tumor infiltration, lymph nodal involvement and survival rate. J Cardiovasc Surg (Torino). 1999 Oct;40(5):737-40.
PubMed 10597014Ma GW, Situ DR, Ma QL, Long H, Zhang LJ, Lin P, Rong TH. Three-field vs two-field lymph node dissection for esophageal cancer: a meta-analysis. World J Gastroenterol. 2014 Dec 21;20(47):18022-30. doi: 10.3748/wjg.v20.i47.18022.
PubMed 25548502Ye K, Xu JH, Sun YF, Lin JA, Zheng ZG. Characteristics and clinical significance of lymph node metastases near the recurrent laryngeal nerve from thoracic esophageal carcinoma. Genet Mol Res. 2014 Aug 25;13(3):6411-9. doi: 10.4238/2014.August.25.4.
PubMed 25158259Sgourakis G, Gockel I, Lang H. Endoscopic and surgical resection of T1a/T1b esophageal neoplasms: a systematic review. World J Gastroenterol. 2013 Mar 7;19(9):1424-37. doi: 10.3748/wjg.v19.i9.1424.
PubMed 23539431
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematically Mediastinal Lymph Node Dissection (SLND) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06979986
- Acronym / sponsor ID
- FJCHTOSP-1
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 20 May 2025 (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 is a study from Fujian Cancer Hospital Thoracic of Surgery Project, numbered as FJCHTOSP-1. Systematically mediastinal Lymph Node Dissection (SLD) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma: a single-center, prospective clinical trial.
Detailed description
Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepared random tables. Participants in the systematically mediastinal lymph node dissection (SLND) group will receive systematically mediastinal lymph node dissection, while those in the non-SLND group will not receive mediastinal lymph node dissection. The primary endpoint is 3-year disease-free survival (DFS).
The sample size are estimated with reference to investigators' previous data, in which the 3-year DFS was 62.7% for patients diagnosed with T1a Stage Esophageal Squamous Cell Carcinoma and underwent Endoscopic Submucosal Dissection without SLND. Investigators assumed that if 3-year DFS of patients in SLND group was over 80%, then investigatorswould deem the SLND group to be superior to the non-SLND group. The sample size are estimated to be 102. Therefore, the total number of patients enrolled are designed to be 102.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection | Experimental | Procedure: Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node DissectionT1a Stage Esophageal Squamous Cell Carcinoma undergo Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection |
| Endoscopic Submucosal Dissection without Systematically mediastinal Lymph Node Dissection | Placebo comparator | Procedure: Endoscopic Submucosal Dissection without SLNDT1a Stage Esophageal Squamous Cell Carcinoma just recieve Endoscopic Submucosal Dissection treatment, not undergo Systematically mediastinal Lymph Node Dissection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical stage T1aN0M0.
- A lesion detected on Endoscopic Ultrasound featured as T1a stage.
- Age 18 to 75.
- Patients who have signed the informed consent form.
Key exclusion criteria (5 listed)
- • Other than invasive adenocarcinoma by pathological analysis.
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 Dissection with Systematically mediastinal Lymph Node DissectionParticipants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepared random tables. Participants in the SLND group will receive Endoscopic Submucosal Dissection with systematically mediastinal lymph node dissection | Procedure or surgery | Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection |
| Endoscopic Submucosal Dissection without SLNDParticipants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepare random tables. Participants in the non-SLND group will just receive Endoscopic Submucosal Dissection treatment, not undergo Systematically mediastinal Lymph Node Dissection. | Procedure or surgery | Endoscopic Submucosal Dissection without Systematically mediastinal Lymph Node Dissection |
Primary outcome
DFS
Time frame: From enrollment to the end of treatment at 3 years
disease-free survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Results publication: PubMed 9445239Nishihira T, Hirayama K, Mori S. A prospective randomized trial of extended cervical and superior mediastinal lymphadenectomy for carcinoma of the thoracic esophagus. Am J Surg. 1998 Jan;175(1):47-51. doi: 10.1016/s0002-9610(97)00227-4.
- Results publication: PubMed 12170022Altorki N, Kent M, Ferrara C, Port J. Three-field lymph node dissection for squamous cell and adenocarcinoma of the esophagus. Ann Surg. 2002 Aug;236(2):177-83. doi: 10.1097/00000658-200208000-00005.
- Results publication: PubMed 20217248Tong DK, Law S, Kwong DL, Chan KW, Lam AK, Wong KH. Histological regression of squamous esophageal carcinoma assessed by percentage of residual viable cells after neoadjuvant chemoradiation is an important prognostic factor. Ann Surg Oncol. 2010 Aug;17(8):2184-92. doi: 10.1245/s10434-010-0995-2. Epub 2010 Mar 9.
- Results publication: PubMed 14662544Tachibana M, Kinugasa S, Yoshimura H, Dhar DK, Nagasue N. Extended esophagectomy with 3-field lymph node dissection for esophageal cancer. Arch Surg. 2003 Dec;138(12):1383-9; discussion 1390. doi: 10.1001/archsurg.138.12.1383.
- Results publication: PubMed 10903602Ando N, Ozawa S, Kitagawa Y, Shinozawa Y, Kitajima M. Improvement in the results of surgical treatment of advanced squamous esophageal carcinoma during 15 consecutive years. Ann Surg. 2000 Aug;232(2):225-32. doi: 10.1097/00000658-200008000-00013.
- Results publication: PubMed 24612702Hsu PK, Huang CS, Wang BY, Wu YC, Hsu WH. Survival benefits of postoperative chemoradiation for lymph node-positive esophageal squamous cell carcinoma. Ann Thorac Surg. 2014 May;97(5):1734-41. doi: 10.1016/j.athoracsur.2013.12.041. Epub 2014 Mar 6.
- Results publication: PubMed 21327531Hsu PK, Wang BY, Huang CS, Wu YC, Hsu WH. Prognostic factors for post-recurrence survival in esophageal squamous cell carcinoma patients with recurrence after resection. J Gastrointest Surg. 2011 Apr;15(4):558-65. doi: 10.1007/s11605-011-1458-1. Epub 2011 Feb 15.
- Results publication: PubMed 25031273Merkow RP, Bilimoria KY, Keswani RN, Chung J, Sherman KL, Knab LM, Posner MC, Bentrem DJ. Treatment trends, risk of lymph node metastasis, and outcomes for localized esophageal cancer. J Natl Cancer Inst. 2014 Jul 16;106(7):dju133. doi: 10.1093/jnci/dju133. Print 2014 Jul.
- Results publication: PubMed 25527100Chen J, Wu S, Zheng X, Pan J, Zhu K, Chen Y, Li J, Liao L, Lin Y, Liao Z. Cervical lymph node metastasis classified as regional nodal staging in thoracic esophageal squamous cell carcinoma after radical esophagectomy and three-field lymph node dissection. BMC Surg. 2014 Dec 19;14:110. doi: 10.1186/1471-2482-14-110.
- Results publication: PubMed 22105736Li H, Yang S, Zhang Y, Xiang J, Chen H. Thoracic recurrent laryngeal lymph node metastases predict cervical node metastases and benefit from three-field dissection in selected patients with thoracic esophageal squamous cell carcinoma. J Surg Oncol. 2012 May;105(6):548-52. doi: 10.1002/jso.22148. Epub 2011 Nov 21.
- Results publication: PubMed 15701501Tachibana M, Kinugasa S, Yoshimura H, Shibakita M, Tonomoto Y, Dhar DK, Nagasue N. Clinical outcomes of extended esophagectomy with three-field lymph node dissection for esophageal squamous cell carcinoma. Am J Surg. 2005 Jan;189(1):98-109. doi: 10.1016/j.amjsurg.2004.10.001.
- Results publication: PubMed 10597014Tabira Y, Kitamura N, Yoshioka M, Tanaka M, Nakano K, Toyota N, Mori T. Significance of three-field lymphadenectomy for carcinoma of the thoracic esophagus based on depth of tumor infiltration, lymph nodal involvement and survival rate. J Cardiovasc Surg (Torino). 1999 Oct;40(5):737-40.
- Individual participant dataSharing planned: No. Individual patient data will not be shared due to privacy regulations and restrictions stipulated by the ethics committee approval. Research participants were not informed during the consent process that their data might be widely shared. Additionally, this trial involves sensitive medical information that carries potential re-identification risks even after de-identification procedures. However, researchers interested in specific analyses are welcome to discuss potential collaboration through appropriate data use agreements.
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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.
Weimin Fang principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection and Endoscopic Submucosal Dissection without SLND in people with Esophageal Cancer, run by Fujian Cancer Hospital.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruirong Lin, Ph.D (0591-62752788, lrr003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: From enrollment to the end of treatment at 3 years). 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 NCT06979986, which also lists 27 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 20 May 2025.