Esophageal CancerNCT01555801
Endoscopic Ultrasound Plus Submucosal Injection for Early Esophageal Cancer
A study testing submucosal injection needle ; EUS and ordinary endosonography(EUS) in people with Esophageal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Preoperative accurately staging T1a or T1b in early esophageal cancer is vital for the choices of treatment. At present, the main diagnostic method for early esophageal cancer is endoscopic ultrasound (EUS). However, the accuracy of EUS alone is poor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- submucosal injection needle ; EUS and ordinary endosonography(EUS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old, no gender limited;
- Patients with esophageal squamous cell carcinoma who be confirmed by ordinary endoscopy and pathologic biopsy;
- Patients who agree to accept endoscopic resection or surgical excision of the lesion in esophagus;
- patients with normal cardio-pulmonary function and normal coagulative function,are predicted to be tolerated anesthesia and surgery;
- patients who understand test purpose, volunteer to join these study and sign the consent inform.
Who cannot join
- Patients with stages of T2, T3, or T4 displayed by EUS;
- Patients who can't tolerate endoscopy and surgical treatment for various reasons;
- Patients who have distant metastasis, or multiple source of malignant tumors;
- Patients with blood coagulative disorder;
- Patients don't accept the endoscopic examination or surgical treatment;
- Patients with poor compliancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
cancer center, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Jian-jun Li, M.D. Ph.D, 86-2087343381, lijj@sysucc.org.cn
Jian-jun Li, M.D. Ph.D.
About this study
Official title: Efficacy Study of Endoscopic Ultrasound Combining With Submucosal Saline Injection for Pretreatment Staging of T1a and T1b in Patients With Early Esophageal Cancer
Preoperative accurately staging T1a or T1b in early esophageal cancer is vital for the choices of treatment. At present, the main diagnostic method for early esophageal cancer is endoscopic ultrasound (EUS). However, the accuracy of EUS alone is poor. Thus, it is necessary to improve endoscopic ultrasound examination methods. This project is concerning on the efficacy of EUS combining with submucosal injection of saline for staging T1a and T1b-esophageal cancer. Patients and methods: 80 cases of pathological confirmed early esophageal cancer were randomly divided into two groups: endoscopic ultrasonography group (EUS group) and EUS combining with submucosal injecting saline group (EUS+SIS group). All the cases will be performance by endoscopic or surgical resection; postoperative pathologic diagnosis will be obtained involving echo, depth, margin and other features. The EUS results of two groups of patients will be compared with pathologic results. From comparison, the efficacy and accuracy of EUS+SIS for staging T1a and T1b in esophageal cancer patients will be validated. Through this study, the investigators may develop a routine diagnostic and accurately staging method for early esophageal cancer patients.
Read the detailed description
Someone whom may concern our IPD are available to the PI, Jian-jun Li M.D. or at lijj@sysucc.org.cn
- Conditions
- Esophageal Cancer
- Being tested
- submucosal injection needle ; EUS, ordinary endosonography(EUS)
- Keywords
- esophageal cancer, early cancer, ultrasonography (EUS), stage
- Medical subject headings
- Esophageal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
submucosal injection needle ; EUSDevice
Also called submucosal injection needle:Olympus,NM-20K-0423;, EUS:Olympus,UM2000
The patients will accepted submucosal injection of 5ml saline followed by ordinary endosonography(EUS) before surgery or endoscopic dissection.
ordinary endosonography(EUS)Device
Also called EUS:Olympus,UM2000
These patients will be accepted ordinary EUS followed by surgery or endoscopic dissection.
| Study group | Role | What they receive |
|---|---|---|
| Submucosal injection combining with EUS | Experimental | The enrolled patients will be accepted submucosal injection of saline,then ultrasonography will performed(EUS+SIS group).So,stages of EUS in these early esophageal cancer will be recorded and compared with the pathological stages afer endoscopic mucosal resection(EMR) or endoscopic submucosal dissection(ESD) or esophagectomy. Receives: Device: submucosal injection needle ; EUS |
| ordinary endosonography(EUS) | Placebo comparator | The enrolled patients will accept ordinary ultrasonography .So,stages of EUS in these early esophageal cancer will be recorded and compared with the pathological stages afer endoscopic mucosal resection(EMR) , endoscopic submucosal dissection(ESD) or esophagectomy. Receives: Device: ordinary endosonography(EUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The stages judged from submucosal injection plus EUS or ordinary EUS will be compared with the pathological results after endoscopic or surgical resection.So the sensitivity,specificity,positive predictive value,negative predictive value and diagnostic accuracy of either submucosal injection plus EUS or ordinary EUS for early esophageal cancer will be measured respectivly.
Measured: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
Specificity
As well as sensitivity described above.
Measured: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
Diagnostic accuracy
As well as sensitivity described above.
Measured: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
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 CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-jun Li, Sun Yat-sen University
- Investigators
- Jian-jun Li, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555801
- Sponsor's protocol ID
- 112273
- Other IDs
- 1122
- Status last verified
- Jan 2017
- First submitted
- 29 Feb 2012
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
He LJ, Xie C, Wang ZX, Li Y, Xiao YT, Gao XY, Shan HB, Luo LN, Chen LM, Luo GY, Yang P, Zeng SC, Xu GL, Li JJ. Submucosal Saline Injection Followed by Endoscopic Ultrasound versus Endoscopic Ultrasound Only for Distinguishing between T1a and T1b Esophageal Cancer. Clin Cancer Res. 2020 Jan 15;26(2):384-390. doi: 10.1158/1078-0432.CCR-19-1722. Epub 2019 Oct 15.
PubMed 31615934
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Endoscopic Ultrasound Combining With Submucosal Saline Injection for Pretreatment Staging of T1a and T1b in Patients With Early Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01555801
- Acronym / sponsor ID
- 112273
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer, early cancer, ultrasonography (EUS), stage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Mar 2012 (estimated)
- 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.
Preoperative accurately staging T1a or T1b in early esophageal cancer is vital for the choices of treatment. At present, the main diagnostic method for early esophageal cancer is endoscopic ultrasound (EUS). However, the accuracy of EUS alone is poor. Thus, it is necessary to improve endoscopic ultrasound examination methods. This project is concerning on the efficacy of EUS combining with submucosal injection of saline for staging T1a and T1b-esophageal cancer. Patients and methods: 80 cases of pathological confirmed early esophageal cancer were randomly divided into two groups: endoscopic ultrasonography group (EUS group) and EUS combining with submucosal injecting saline group (EUS+SIS group). All the cases will be performance by endoscopic or surgical resection; postoperative pathologic diagnosis will be obtained involving echo, depth, margin and other features. The EUS results of two groups of patients will be compared with pathologic results. From comparison, the efficacy and accuracy of EUS+SIS for staging T1a and T1b in esophageal cancer patients will be validated. Through this study, the investigators may develop a routine diagnostic and accurately staging method for early esophageal cancer patients.
Detailed description
Someone whom may concern our IPD are available to the PI, Jian-jun Li M.D. or at lijj@sysucc.org.cn
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Submucosal injection combining with EUS | Experimental | Device: submucosal injection needle ; EUSThe enrolled patients will be accepted submucosal injection of saline,then ultrasonography will performed(EUS+SIS group).So,stages of EUS in these early esophageal cancer will be recorded and compared with the pathological stages afer endoscopic mucosal resection(EMR) or endoscopic submucosal dissection(ESD) or esophagectomy. |
| ordinary endosonography(EUS) | Placebo comparator | Device: ordinary endosonography(EUS)The enrolled patients will accept ordinary ultrasonography .So,stages of EUS in these early esophageal cancer will be recorded and compared with the pathological stages afer endoscopic mucosal resection(EMR) , endoscopic submucosal dissection(ESD) or esophagectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years old, no gender limited;
- Patients with esophageal squamous cell carcinoma who be confirmed by ordinary endoscopy and pathologic biopsy;
- Patients who agree to accept endoscopic resection or surgical excision of the lesion in esophagus;
- patients with normal cardio-pulmonary function and normal coagulative function,are predicted to be tolerated anesthesia and surgery;
- patients who understand test purpose, volunteer to join these study and sign the consent inform.
Key exclusion criteria (6 listed)
- Patients with stages of T2, T3, or T4 displayed by EUS;
- Patients who can't tolerate endoscopy and surgical treatment for various reasons;
- Patients who have distant metastasis, or multiple source of malignant tumors;
- Patients with blood coagulative disorder;
- Patients don't accept the endoscopic examination or surgical treatment;
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 |
|---|---|---|
| submucosal injection needle ; EUSAlso: submucosal injection needle:Olympus,NM-20K-0423;, EUS:Olympus,UM2000The patients will accepted submucosal injection of 5ml saline followed by ordinary endosonography(EUS) before surgery or endoscopic dissection. | Device | Submucosal injection combining with EUS |
| ordinary endosonography(EUS)Also: EUS:Olympus,UM2000These patients will be accepted ordinary EUS followed by surgery or endoscopic dissection. | Device | ordinary endosonography(EUS) |
Primary outcome
Sensitivity
Time frame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
The stages judged from submucosal injection plus EUS or ordinary EUS will be compared with the pathological results after endoscopic or surgical resection.So the sensitivity,specificity,positive predictive value,negative predictive value and diagnostic accuracy of either submucosal injection plus EUS or ordinary EUS for early esophageal cancer will be measured respectivly.
Specificity
Time frame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
As well as sensitivity described above.
Diagnostic accuracy
Time frame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
As well as sensitivity described above.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Derived from this study: PubMed 31615934He LJ, Xie C, Wang ZX, Li Y, Xiao YT, Gao XY, Shan HB, Luo LN, Chen LM, Luo GY, Yang P, Zeng SC, Xu GL, Li JJ. Submucosal Saline Injection Followed by Endoscopic Ultrasound versus Endoscopic Ultrasound Only for Distinguishing between T1a and T1b Esophageal Cancer. Clin Cancer Res. 2020 Jan 15;26(2):384-390. doi: 10.1158/1078-0432.CCR-19-1722. Epub 2019 Oct 15.
- Individual participant dataSharing planned: Yes
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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.
Jian-jun Li, M.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing submucosal injection needle ; EUS and ordinary endosonography(EUS) in people with Esophageal Cancer, run by Sun Yat-sen 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 5 inclusion and 6 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 25 Jan 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-jun Li, M.D. Ph.D. (86-2087343381, lijj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days). 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 NCT01555801, 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 25 Jan 2017.