Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04222530 |
| Other study ID # |
V2.0/2019-10-21(NFEC-2019-232) |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 28, 2020 |
| Est. completion date |
December 20, 2022 |
Study information
| Verified date |
December 2019 |
| Source |
Nanfang Hospital of Southern Medical University |
| Contact |
Yue Li, Doctor |
| Phone |
8615975537291 |
| Email |
liyue_1989919[@]126.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this clinical study is to compare the accuracy of linear endoscopic
ultrasonography and magnified narrowband endoscopy in the diagnosis of invasive depth of
early rectal cancer, and to provide more powerful evidence for the choice of surgical methods
for early rectal cancer. Patients with early rectal cancer who will be examined by endoscopic
ultrasonography or magnifying narrowband endoscopy in the department of gastroenterology and
general surgery will be examined by linear endoscopic ultrasonography or magnifying
narrowband endoscopy to examine the depth of invasion of early rectal cancer, and the results
are compared with the postoperative pathological results of the patients as the gold
standard. It provides strong evidence that the accuracy of linear endoscopic ultrasonography
in judging the invasive depth of early colorectal cancer is not inferior to that of
magnifying narrowband endoscopy.
Description:
1. Research purpose. 1.1 main purpose: to provide a more accurate preoperative evaluation
method for the selection of surgical methods for early rectal cancer by comparing the
accuracy of linear endoscopic ultrasonography and magnifying narrowband endoscopy in the
diagnosis of invasive depth of early rectal cancer.
1.2 Secondary purpose: to compare the sensitivity, specificity and examination time of
linear endoscopic ultrasonography and magnified narrowband endoscopy in the diagnosis of
invasive depth of early rectal cancer.
2. Experimental design. This study is a single-center randomized, self-controlled clinical
trial. The subjects were selected according to the inclusion and exclusion criteria, and
all subjects who met the inclusion criteria were required to sign an informed consent
form before joining the group. The team of doctors is composed of four experienced
endoscopes from the Department of Gastroenterology of Nanfang Hospital. Patients were
randomly divided into group A (patients underwent linear endoscopic ultrasonography
followed by magnifying narrowband endoscopy) and group B (patients underwent magnifying
narrowband endoscopy first and then linear endoscopic ultrasonography). The examination
results, examination time and complications were recorded in both groups. After
examination, continue to follow up the patient's operation until the patient's surgical
and pathological results are obtained.
The main observation indicators of this clinical study include the accuracy of linear
endoscopic ultrasonography and magnifying narrowband endoscopy in the diagnosis of the
invasive depth of early rectal cancer, in which the surgical and pathological results
are the gold standard, and the examination time of the two methods are also compared.
3. data analysis. After examination, continue to follow up the patient's operation until
the patient's surgical and pathological results are obtained. Patients who did not
undergo surgery and patients whose surgical and pathological results were not consistent
with rectal cancer were excluded. The remaining patients took the pathological results
as the gold standard to calculate the accuracy, sensitivity and specificity of linear
endoscopic ultrasonography and endoscopic narrowband imaging in the diagnosis of
invasive depth of early rectal cancer, and the results were statistically analyzed by
chi-square test.
4. Safety monitoring, reporting and medical treatment. 4.1 adverse event (AE) definition.
An adverse event refers to any adverse medical event that occurs after the patient or
subject is examined in this study, which does not necessarily have a causal relationship
with the examination. Therefore, adverse events can be any adverse physical signs
(including abnormal laboratory results), symptoms, or diseases associated with the use
of this study test, regardless of whether or not there is a causal relationship with the
study test. Adverse events include serious adverse events ((Serious Adverse Event, SAE))
and non-serious adverse events.
4.2 SAE definition.
SAE refers to medical events during clinical trials, such as requiring hospitalization or
prolonging hospitalization, disability, affecting working ability, endangering life or death,
leading to congenital deformities and so on. Includes the following medical events:
1. events leading to death;
2. a life-threatening event (defined as the risk of the subject's immediate death at the
time of the event);
3. events requiring hospitalization or prolonging the duration of hospitalization;
4. events that can lead to permanent or severe disability / insufficiency / affect work
ability;
5. congenital abnormality or birth defect; Other important medical events (defined as
events that endanger the subject or require intervention to prevent the occurrence of
any of the above).
4.3. Adverse event recording, collection, reporting and handling. 4.3.1 Collection, reporting
and processing of AE. After signing the informed consent form and prior to the inspection of
this study, all AE related to the operating procedures specified in the test scheme should be
recorded in the CRF.
The records of the AE shall include the description of AE and all related symptoms, time of
onset, severity, duration, relevance to the trial drug, action taken, and final outcome and
outcome. AE records must use medical terms, and if the subjects' symptoms and signs can be
summed up by a common cause, the diagnosis should be recorded as far as possible. Except for
the indicators related to disease progression, all clinical events and laboratory adverse
reactions with clinical significance can be dealt with with reference to the evaluation
criteria for common adverse events ((CTCAE) version 5.0). Adverse reactions caused by the
treatment will be recorded by the researchers.
4.3.2 Collection and reporting of SAE. From the time the subjects signed the informed consent
form to the completion of the study, all SAE, regardless of the cause or relevance to the
inspection of this study, need to be reported by using the SAE report form. In the event of
SAE, researchers should immediately take appropriate treatment measures to ensure the safety
of the subjects, and report to the applicant for drug registration, the State Drug
Administration, the Provincial Food and Drug Administration, the ethics committee of the
corresponding clinical trial center and the Medical Department of the Medical Administration
and Hospital Administration within 24 hours, and promptly report to the ethics committee of
the team leader. As far as possible, the first report should include the following: the
source of the report, the items examined in this study, the name of serious adverse events,
the time of occurrence, severity, duration, relevance to experimental drugs, measures taken
and outcomes.
4.3.3 AE severity criteria.
The researchers will evaluate the severity of the disease based on the five-level criteria
developed by the NCI CTCAE5.0 version:
Grade 1, mild; asymptomatic or mild signs; only clinical or diagnostic observation without
medical intervention; Grade 2, moderate; age-related limited functions of daily life (such as
cooking, shopping, phone calls, etc.); Grade 3, serious or medically important but not
immediately life-threatening; leading to or prolonging the length of hospital stay;
disability; activities of daily self-care are limited (activities of daily self-care:
bathing, dressing, undressing, eating, going to the toilet, taking medicine, etc., but not
bedridden); Level 4, life-threatening and in need of emergency treatment; Level 5, AE-related
death. 4.3.4 other responsibilities of researchers during follow-up of serious adverse
events.
Researchers should examine and treat serious adverse events according to clinical judgment,
including necessary clinical laboratory examination, physical examination and so on. Any
examination results or other updated SAE-related information must be followed up. The time
limit and procedure of the follow-up report are the same as those of the initial report.
5. Trial termination / suspension criteria. 5.1 the organizer has the right to terminate /
suspend this study. Before terminating / suspending a clinical study, the sponsor must notify
the researcher, the ethics committee and the relevant regulatory authorities and state the
reasons. After the early termination / suspension of the study, the resumption of the study
must be reviewed and approved by the Ethics Committee.
5.2 termination / suspension requested by the Ethics Committee.
6. The rule to end clinical trials.
The experiment ends when all the subjects meet the following conditions:
1. include at least the number of valid cases.
2. serious safety problems or serious adverse events occur.
3. there are major mistakes in the test scheme.
4. the organizer asks for termination.
7. Data management. 7.1 data Management. The main contents are as follows: 1) researchers
must ensure that the data are true, complete and accurate; 2) when making any corrections,
the test records can only be underlined, side notes on the revised data, explain the reasons,
signed and dated by the researchers, and shall not be scrubbed or overwritten the original
records; 3) the items of laboratory inspection are complete. 7.2. Data recording and file
saving. The data about the subjects on the case report form should be recorded in the way of
the subject code, and the subjects can only be identified by the subject code or their
initials.
This study uses EXCEL for data management: from the data entry to the verification
requirements of the source data, to the query and answer of the quality control data, and
finally to the operation of data locking and export. After confirming that there is no doubt
about the data, the parties sign the database locking application form, and the database is
locked by the data administrator. After the database is locked, the analysis database is
exported by the data administrator and handed over to the statisticians for statistical
analysis. The locked data can no longer be edited, and the problems found after the database
is locked can be corrected in the statistical analysis program after confirmation.
8. Statistic analysis. 8.1 sample size determination. After consulting the relevant
literature, investigators found that the accuracy, sensitivity and specificity of magnifying
narrowband endoscopy in the diagnosis of the depth of early rectal cancer invasion were about
90%, 75% and 90%, respectively. According to the previous research results of our team, the
accuracy, sensitivity and specificity of linear endoscopic ultrasound in the diagnosis of
early rectal cancer invasion were about 93%, 75% and 96%, respectively. Therefore,
investigators speculate that the accuracy of linear endoscopic ultrasonography in the
diagnosis of invasive depth of early rectal cancer is not inferior to that of magnifying
narrowband endoscopy, and the non-inferiority threshold is set at 10%. By setting the
bilateral test level is 0.025, the test efficiency (power) is 80%, according to the 1:1
ratio, calculated by PASS16.0 software, each group needs Nylon 73, plus the shedding rate is
10%, each group has at least 81 cases, because this study is a self-control study, so a total
of 81 patients with early rectal cancer are needed.
8.2 Statistical methods. The measurement data are described by mean and standard deviation,
and the counting data are described by examples and percentage. Chi-square test was used to
evaluate the diagnostic accuracy, sensitivity and specificity of the two methods. A P value
less than or equal to 0.05 will be considered to have a statistically significant difference
between the test group and the control group. SPSS20.0 statistical software was used to
analyze the indexes of the two groups respectively.
8.3 Statistical software and general requirements: The observational indexes of the two
groups were statistically analyzed by SPSS20.0 statistical software.
