Esophageal CancerPhase 1ESINCT01930630
ESI With EUS to Differentiate T3 and T4 ESCC
A Phase 1 study testing Extraesophageal saline injection (ESI) in people with Esophageal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
By using a novel technique of extraesophageal saline injection (ESI),the esophagus is to be separate from the adjacent organs.The space between esophagus and adjacent organs can be detected by endoscopic ultrasonography enhanced with ESI.Therefore, ESI plus with EUS is to be differentiate between T3 and T4 stage… 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?
- Extraesophageal saline injection (ESI)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2014
- Phase
- Phase 1
- 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
- A)Age ranges 18-65 years old, no gander limited;
- B)Patients with advanced ESCC (T2-T4) who were confirmed by standard endoscopy and pathologic biopsy;
- C)Patients who agree to accept esophagectomy;
- D)Patients with normal cardio-pulmonary and blood coagulation function; patients were predicted to be tolerated anesthesia and surgery;
- E)Patients who understand the study, are willing to join this study and sign consent inform;
Who cannot join
- Patients with early ESCC of Tis,T1a and T1b stages detected by standard EUS;
- Patients cannot tolerate endoscopy and esophagectomy with various reasons;
- Patients who have distant metastatic disease or multiple source of malignant tumor;
- Patients with blood coagulation disorder;
- Patients don't accept endoscopic or surgical resection subsequently;
- Patients with poor compliancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Xin-xi Zhou, MD, +862087343135, zhouxx@sysucc.org.cn
Jian-jun Li, MD & PhD
About this study
Official title: Extraesophageal Saline Injection Combined With EUS to Differentiate Between T3 and T4 Stage Esophageal Squamous Cell Carcinoma - A PhaseⅠTrial
By using a novel technique of extraesophageal saline injection (ESI),the esophagus is to be separate from the adjacent organs.The space between esophagus and adjacent organs can be detected by endoscopic ultrasonography enhanced with ESI.Therefore, ESI plus with EUS is to be differentiate between T3 and T4 stage esophageal squamous cell carcinoma (ESCC). The objective of this Phase Ⅰstudy is to confirm the safety and efficacy of ESI.
Read the detailed description
Esophageal cancer (EC) is one of the most common malignant tumors in the world, and China has the highest incidence of esophageal squamous cell carcinoma (ESCC).According to the TNM staging system of the Union for International Cancer Control (UICC) (7th Edition, 2012), EC invades the esophageal adventitia at the T3 stage; invades the pleura, pericardium and diaphragm at the T4a stage; and involves adjacent vital organs (mainly the thoracic aorta, aortic arch, trachea, tracheal bifurcation, and spine) at the T4b stage.It is considered that T3- and T4a-stage tumors can be surgically resected, while tumors at the T4b stage are not suitable for surgical resection.Therefore, it is important for physicians and patients to know whether the tumor has metastasized to adjacent organs before considering resection. The preoperative stage is unclear in many cases of progressive disease and the involvement of vital organs is only discovered by exploratory thoracotomy, because of which the resection may need to be terminated prematurely, leading to unnecessary injuries.Therefore, accurate preoperative staging of EC, especially during the later stages, is important for deciding the appropriate therapeutic option and evaluation of the prognosis.
The imaging methods used for preoperative staging of EC include endoscopic ultrasonography (EUS). However, EUS has poor accuracy in advanced ESCC, especially in T3 and T4 stage ESCC. Therefore, it is necessary to improve the preoperative accuracy of EUS for advanced EC.
Since extraesophageal space contains loose connective tissue and saline can permeate into extraesophageal space and separate esophagus from adjacent organ; furthermore, saline serves as an EUS contrast agent (negative) and is detected by EUS.Therefore, we envisaged that if saline is directly injected into extraesophageal space, the separation between the esophageal adventitia and its adjacent organs (especially the thoracic aorta, arcus aortae, and tracheal bifurcation) can be observed by EUS. In our recent experiment in canine model, guided by EUS,extraesophageal saline injection was successfully conducted and saline separated esophageal adventitia from adjacent organs including thoracic aorta, arcus aortae, trachea and bronchial bifurcation without any complication.
- Conditions
- Esophageal Cancer
- Being tested
- Extraesophageal saline injection (ESI)
- Keywords
- extraesophageal saline injection (ESI);, esophageal squamous cell carcinoma (ESCC);, esophageal cancer;, endoscopic ultrasonography (EUS)
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraesophageal saline injection (ESI)Device
Also called Extraesophageal saline injection;, Mucosal needle;, EUS:Fujinon7000(EG-530UR and EG-530UT)
The patients with advanced ESCC are to undergo extraesophageal injection of 15ml saline preoperatively and subsequently detected by EUS to confirm whether saline separates esophagus from adjacent organs.
| Study group | Role | What they receive |
|---|---|---|
| Extraesophageal saline injection (ESI) | Experimental | Extraesophageal saline injection (ESI) guided by EUS in patients with advanced ESCC preoperatively Receives: Device: Extraesophageal saline injection (ESI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Adverse events included bleeding due to great vessel split, asphyxia, esophageal perforation, acute heart failure or acute mediastinum inflammation during/post ESI.
Measured: 10 days
Secondary outcomes (1)
Efficacy of extraesophageal saline separating esophagus from adjacent organs detected by EUS or computerized tomography (CT) just after ESI
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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, MD & PhD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930630
- Sponsor's protocol ID
- ESI-2013
- Other IDs
- 2012-FXY-006
- Acronym
- ESI
- Status last verified
- Aug 2013
- First submitted
- 20 Aug 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extraesophageal Saline Injection Combined With EUS to Differentiate Between T3 and T4 Stage Esophageal Squamous Cell Carcinoma - A PhaseⅠTrial
- ClinicalTrials.gov ID
- NCT01930630
- Acronym / sponsor ID
- ESI / ESI-2013
- Conditions
- Esophageal Cancer
- Keywords
- extraesophageal saline injection (ESI);, esophageal squamous cell carcinoma (ESCC);, esophageal cancer;, endoscopic ultrasonography (EUS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 29 Aug 2013 (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.
By using a novel technique of extraesophageal saline injection (ESI),the esophagus is to be separate from the adjacent organs.The space between esophagus and adjacent organs can be detected by endoscopic ultrasonography enhanced with ESI.Therefore, ESI plus with EUS is to be differentiate between T3 and T4 stage esophageal squamous cell carcinoma (ESCC). The objective of this Phase Ⅰstudy is to confirm the safety and efficacy of ESI.
Detailed description
Esophageal cancer (EC) is one of the most common malignant tumors in the world, and China has the highest incidence of esophageal squamous cell carcinoma (ESCC).According to the TNM staging system of the Union for International Cancer Control (UICC) (7th Edition, 2012), EC invades the esophageal adventitia at the T3 stage; invades the pleura, pericardium and diaphragm at the T4a stage; and involves adjacent vital organs (mainly the thoracic aorta, aortic arch, trachea, tracheal bifurcation, and spine) at the T4b stage.It is considered that T3- and T4a-stage tumors can be surgically resected, while tumors at the T4b stage are not suitable for surgical resection.Therefore, it is important for physicians and patients to know whether the tumor has metastasized to adjacent organs before considering resection. The preoperative stage is unclear in many cases of progressive disease and the involvement of vital organs is only discovered by exploratory thoracotomy, because of which the resection may need to be terminated prematurely, leading to unnecessary injuries.Therefore, accurate preoperative staging of EC, especially during the later stages, is important for deciding the appropriate therapeutic option and evaluation of the prognosis.
The imaging methods used for preoperative staging of EC include endoscopic ultrasonography (EUS). However, EUS has poor accuracy in advanced ESCC, especially in T3 and T4 stage ESCC. Therefore, it is necessary to improve the preoperative accuracy of EUS for advanced EC.
Since extraesophageal space contains loose connective tissue and saline can permeate into extraesophageal space and separate esophagus from adjacent organ; furthermore, saline serves as an EUS contrast agent (negative) and is detected by EUS.Therefore, we envisaged that if saline is directly injected into extraesophageal space, the separation between the esophageal adventitia and its adjacent organs (especially the thoracic aorta, arcus aortae, and tracheal bifurcation) can be observed by EUS. In our recent experiment in canine model, guided by EUS,extraesophageal saline injection was successfully conducted and saline separated esophageal adventitia from adjacent organs including thoracic aorta, arcus aortae, trachea and bronchial bifurcation without any complication.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extraesophageal saline injection (ESI) | Experimental | Device: Extraesophageal saline injection (ESI)Extraesophageal saline injection (ESI) guided by EUS in patients with advanced ESCC preoperatively |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A)Age ranges 18-65 years old, no gander limited;
- B)Patients with advanced ESCC (T2-T4) who were confirmed by standard endoscopy and pathologic biopsy;
- C)Patients who agree to accept esophagectomy;
- D)Patients with normal cardio-pulmonary and blood coagulation function; patients were predicted to be tolerated anesthesia and surgery;
- E)Patients who understand the study, are willing to join this study and sign consent inform;
Key exclusion criteria (6 listed)
- Patients with early ESCC of Tis,T1a and T1b stages detected by standard EUS;
- Patients cannot tolerate endoscopy and esophagectomy with various reasons;
- Patients who have distant metastatic disease or multiple source of malignant tumor;
- Patients with blood coagulation disorder;
- Patients don't accept endoscopic or surgical resection subsequently;
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 |
|---|---|---|
| Extraesophageal saline injection (ESI)Also: Extraesophageal saline injection;, Mucosal needle;, EUS:Fujinon7000(EG-530UR and EG-530UT)The patients with advanced ESCC are to undergo extraesophageal injection of 15ml saline preoperatively and subsequently detected by EUS to confirm whether saline separates esophagus from adjacent organs. | Device | Extraesophageal saline injection (ESI) |
Primary outcome
Number of participants with adverse events
Time frame: 10 days
Adverse events included bleeding due to great vessel split, asphyxia, esophageal perforation, acute heart failure or acute mediastinum inflammation during/post ESI.
1 secondary outcome
Efficacy of extraesophageal saline separating esophagus from adjacent organs detected by EUS or computerized tomography (CT) just after ESI
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
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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, MD & PhD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Extraesophageal saline injection (ESI) 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 29 Aug 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, MD & PhD (+862087343381, lijj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: 10 days). 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 29 Aug 2013.