Neoplasms

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Rectal Diseases

* Patients older than 18 years
* Diagnosis of rectal cancer
* Inferior edge of the tumour not further than 2 cm above the anorectal ring
* Clinical TNM staging T1N0M0

Transanal local excision

Rodrigo Tovar Perez, MD

Carlos Cerdán Santacruz, PhD

Óscar Cano Valderrama, PhD

Francisco Jiménez Escovar, PhD

Blas Flor Lorente, PhD

Javier García Septiem, PhD

Rodrigo Oliva Pérez, PhD

Rectal cancer is one of the most frequent malignant tumors nowadays. There are several possible treatment options including chemotherapy, radiotherapy and surgery. Surgery for early stage rectal cancer can be either a radical surgery (RS) or a local excision (LE).

A radical surgery removes the rectum including the tumor and the lymph nodes through which it spreads, improving survival but with a possible impact in the patients quality of life (QoL). A local excision only removes the tumor and a safety margin of healthy rectum. This has the potential to avoid the possible complications and QoL decrease. However there are some complications after a LE and also poor prognostic factors inherent to the tumor biology that can lead the surgical team to perform a RS after LE with worse outcomes. These are impossible to know before the procedure.

The goal of this registry is to determine the frequency of these poor prognostic biological factors and complications in patients undergoing LE for early rectal cancer.

The main question it aims to answer are:

• How frequently does LE allow for rectum preservation?

Participants will undergo LE for early rectal cancer when it is considered the best treatment by their surgeons according to their expertise and protocols. Patients will follow the standard treatment that would be given to them, and the biological prognostic factors and the appearance of complications will be recorded.

Registry´s main hypothesis:

Exclusive LE is insufficient for in situ rectum preservation in cT1N0M0 extraperitoneal rectal adenocarcinoma in ≥20% of the patients treated with this approach in real everyday´s clinical practice.

A database will be design recording demographics, tumor details, type of intervention, complications, histological details and further necessity of treatments and rectal preservation along time. It will be hosted online through the REDCap system.

Data entry will be done baseline, after surgical procedure, and at different follow-up periods, at 30 postoperative day and at 6, 12, 18, 24 and 36 months after surgical intervention.

Sample size calculation:

Previous evidence states that most patients would be willing to assume a recurrence risk of 20% (IQR 10-35%) in locally advanced rectal cancer after chemo-radiotherapy in order to join the watch and wait strategy for organ preservation. In the project the investigators propose a salvage TME rate of less than 20% at three years to be acceptable. With this approach, accepting a risk α of 0.05 and a risk β of 0.2, a two-tailed test would require a total of 145 patients to identify a difference of 0.1 units. A proportion in the reference group of 0.2 and a loss rate of 5% has been estimated.

Clinical variables

Clinical and demographic data will be collected from each patient, using their computerised clinical history, and a data collection notebook will be prepared.

* Centre code: Each participating centre will receive a unique code that will be the first variable in the database in order to identify the participation of each centre in the study.
* Patient code: Each patient included in each centre will receive a consecutive numerical code to identify the different cases registered in the study.
* Demographic variables: Sex, date of birth, weight (kg), height (cm).
* Comorbidities and cardiovascular risk factors: ASA classification, diabetes mellitus, hypertension, dyslipidaemia, smoking, heart disease, immunosuppression.
* Preoperative laboratory values: haemoglobin (mg/dl), albumin (mg/dl), carcinoembryonic antigen (mg/dl).
* Preoperative clinical staging: Tests performed (MRI, endoanal ultrasound, endoscopic techniques), distance of the tumour to the ano-rectal ridge, distance of the tumour to the external anal margin, tumour size (cranial-caudal axis), percentage of rectal circumference occupation (\<25%, 25-50%, \>50%).
* Operative data: Date of resection, resection approach (endoscopic vs. surgical), transanal resection devices (TEM, TEO, TAMIS, Robot-TAMIS), technique used (local full-wall resection vs. submucosal dissection), intraoperative complications (bleeding, vaginal perforation, tumour perforation/rupture), medical complications).
* Postoperative complications: Clavien-Dindo classification, wound dehiscence, surgical site infection, bleeding.
* Pathological data: pT classification, histological grade, circumferential margins, vascular, lymphatic and perineural infiltration, micron infiltration of submucosa and tumour budding.
* Need to complete treatment: Reason (local resection complication, high risk factors, inadequate surgical margins, piecemeal resection, local recurrence, final pathological staging greater than pT1), radical surgery (dichotomous), technique used (total mesorectal excision, abdominoperineal amputation of rectum), time from local excision to radical surgery (date), stoma preparation (dichotomous), type of stoma (ileostomy vs. Colostomy, temporary vs. definitive), transit reconstruction within the study period (in temporary stomas), adjuvant radiotherapy, adjuvant radio-chemotherapy,
* Follow-up: complications recorded prospectively at 60 days by means of periodic visits to the coloproctology clinic, with the end of follow-up for the patient within the study being the annual check-up. The number of consultations during the first year, recurrence (indicating date and management) and death will be assessed. Oncological follow-up will be carried out with control of tumour markers (CEA), control imaging tests (CAT scan associated with PET/CT in the case of recurrence), and selected biopsies according to the results.

Statistical method:

The data obtained from each patient will be entered into a database and the analysis will be performed with a statistical programme Stata 13.1 (StataCorp, Texas, USA).

A descriptive analysis of demographic and clinical variables will be performed. Categorical variables will be presented as percentages and frequencies. Qualitative variables will be presented as percentages and frequencies. Quantitative variables will be described as mean and standard deviation (SD) if they follow a normal distribution or as median and interquartile range (IQR), in case of skewness.

The association between the variables collected and the target variables of the study will be performed by Pearson's Chi-square test or Fisher's exact test, as appropriate, in the case of categorical variables and, for continuous variables, by Student's t-test for independent samples or Mann-Whitney U-test, respectively, depending on whether or not their distribution conforms to the normal distribution.

Overall survival, disease-free survival, local recurrence-free survival and overall mesorectal resection-free survival will be estimated using the Kaplan-Meier method and the Cox proportional hazards model. Patients lost to follow-up will be censored.

Chronogram and study´s stages:

* March - September, 2023: Study´s protocol design and approval by the promoter center´s local ethics committee. Recruitment period for other participant centers.
* October,- December 2023: Unique registry database design in the REDCap platform.
* January 2024 - December 2024: Recruitment of the necessary cases according to the sample size calculation.
* January - December 2025: 1-year follow-up of patients included in the study.
* January - April 2026: Interim analysis after the first year of oncologic follow-up for assessment of the primary endpoint of the study (organ preservation with exclusive local resection) as well as some of the secondary endpoints.
* December 2027: Follow-up period to complete the study at 3 years.

Ethical and legal aspects:

The investigation will be conducted according to the 2013 Fortaleza´s update of the the Helsinki Declaration, and to each participant´s country law.

Rectal cancer transanal local excision specimen

Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment

Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment (LORENA Trial).

Rate of patients with no need of Total Mesorectal Excision after follow-up

Postoperative complication rate, description, and severity according to Clavien Dindo classification

Describe the rate of margin tumor infiltration

Describe the rate of lymphatic, vascular and perineural invasion, histological grade, mean submucosal invasion depth

Describe the quality of Total Mesorectal Excision specimen in terms of mesorectal fascia integrity

Hospital Alemão Oswaldo Cruz

Hospital Universitario La Fe

Complejo Hospitalario Universitario de Vigo

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Ploidy and tumour:stromal ratio measurements will be made on specimens of early rectal cancer removed by transanal endoscopic microsurgery (TEM)

Ploidy and tumour:stromal ratio measurements

Chris Cunningham, MD

Early rectal cancer can be removed by minimally-invasive surgery, and the standard pathological assessment of the removed tumour gives valuable information about how advanced the tumour is. This gives an indication of how likely the cancer is to recur, so doctors and patient can decide on the most appropriate further treatment and follow-up. However there is still much uncertainty in these predictions about recurrence. This study will assess two further pathology tests, ploidy and stroma ratio in the tumour, by correlating the results with outcome. This will determine whether these two tests provide additional value in predicting outcome. If so, clinicians would be better able to advise patients with early rectal cancer about their prognosis and further management.

Early rectal cancer can be removed by minimally-invasive surgery, and the standard pathological assessment of the removed tumour gives valuable information about how advanced the tumour is. This information is very important in indicating whether the cancer is likely to recur, and therefore in advising the patient after surgery whether further treatment is advisable, and if not, what is the most appropriate follow-up regime. However there is still a lot of uncertainty in these predictions about recurrence of the cancer, and better tests are being sought. This study aims to look at two further pathology tests, ploidy and stroma ratio in the tumour, and correlate these test results with outcome in patients who have had an early rectal cancer removed. This will allow the investigators to assess whether these two tests provide additional value in predicting outcome. If so, clinicians would be better able to advise patients with early rectal cancer about their prognosis and further management.

Routine histopathology analysis of a rectal cancer specimen removed at surgery includes assessment of tumour size, depth of invasion, vascular, lymphatic and perineural invasion, tumour involvement of resection margins and nodal involvement. This information is valuable in predicting outcome. For example, predicted rates of local recurrence at 36 months following local excision of rectal cancer by transanal endoscopic microsurgery (TEM) based on tumour size, depth of invasion and lymphatic invasion have been tabulated. However such models are not perfect, and leave room for improvement. Ploidy and stroma ratio are two further tests which have shown some promise in predicting outcome.

Ploidy refers to the number of sets of chromosomes in a cell nucleus. Most human cells are normally diploid, with two sets of 23 chromosomes. Abnormal tumour cells may have a different number of sets of chromosomes, or be aneuploid, having some replicated or deleted chromosomes. In general, aneuploidy in cancer cells is associated with a worse prognosis. An early study of DNA ploidy in rectal cancer using flow cytometry showed an independent but small predictive effective of aneuploidy on survival. Technological advances now allow more accurate and detailed assessment of ploidy. The DNA ploidy status of tumour cells in early ovarian cancer has been found to predict which patients will benefit from adjuvant chemotherapy after surgery to remove the ovarian tumour and is used routinely in some centres to aid in decision-making.

Stroma ratio refers to the tumour: stroma ratio. A lower proportion of tumour cells or, conversely, a higher percentage of stroma, in a cancer tends to be associated with a poorer prognosis. This ratio has been found to be strongly associated with tumour growth and invasion in colorectal cancers, and to independently predict survival in patients undergoing surgery to removal colorectal tumours. However previous studies have looked mainly at more advanced colon cancers, rather than early rectal cancers, and have used only cancer-related death as the endpoint, rather than looking at local recurrence and response to adjuvant treatments.

Specimens of early rectal cancer removed by transanal endoscopic microsurgery, which are routinely retained, will be further analysed.

Ploidy and Stroma in Early Rectal Cancer

An Observational Study to Correlate the Results of Ploidy and Stroma Analysis With Prognosis in Early Rectal Cancer

No individual data will be made available

Results of ploidy status will be correlated with patient follow-up information for between 6 months and 9 years following surgery, to look for any correlation with local recurrence of the rectal cancer

Results of tumour:stromal ratio (TSR) will be correlated with patient follow-up information for between 6 months and 9 years following surgery, to look for any correlation with local recurrence of the rectal cancer. A 50% cut-off is used to define high TSR.

Results of ploidy status will be correlated with patient follow-up information for between 6 months and 9 years following surgery, to look for any correlation between the test results and overall survival

Results of tumour:stromal ratio (TSR) will be correlated with patient follow-up information for between 6 months and 9 years following surgery, to look for any correlation between the test results and overall survival. High TSR is defined using a 50% cut-off.

Oslo University Hospital

Oxford University Hospitals NHS Trust

Consultant colorectal surgeon

Patients

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United Kingdom

Region of Enrollment

Tumour component of the TNM (Tumour, Node, Metastasis) staging system determined by histopathological analysis of the resected tumour.

Tumour stage

Post-TEM management

Dr Helen Jones

Only patients for whom ploidy status was available were included in the analysis (ploidy assessment failed in 3 patients for technical reasons)

Correlation Between Ploidy Status With Local Recurrence of Cancer

Correlation Between Tumour: Stroma Ratio With Local Recurrence of Cancer

Correlation Between Ploidy Status and Overall Survival After TEM Surgery to Remove Rectal Cancer

Correlation Between Tumour:Stroma Ratio and Overall Survival After TEM Surgery to Remove Rectal Cancer

All patients. This is an observational study; no interventions were used.

Overall Study

patients underwent linear endoscopic ultrasonography followed by magnifying narrowband endoscopy

patients underwent magnifying narrowband endoscopy followed by linear endoscopic ultrasonography

Linear endoscopic ultrasonography followed by magnifying narrow band endoscopy are used to determine the depth of invasion of early rectal cancer.

Linear EUS first

Magnifying narrow band endoscopy followed by linear endoscopic ultrasonography are used to determine the depth of invasion of early rectal cancer.

ME-NBI first

Yue Li, Doctor

Side Liu, Doctor

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.

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.

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.

All the subjects who met the inclusion criteria were required to sign an informed consent form before joining the group, but they did not know their own grouping. 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). Different examination items are examined by randomly selected doctors, and the two doctors do not know the diagnosis of the other test. 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 Diagnosis of Invasive Depth of Early Rectal Cancer

A Randomized Controlled Clinical Study on the Accuracy of Linear Endoscopic Ultrasonography and Magnifying Narrowband Endoscopy in the Diagnosis of Invasive Depth of Early Rectal Cancer

In order to protect privacy, investigators intend not to disclose the information of the participants.

The pathological T staging of rectal cancer was selected as the gold standard. The preoperative T staging diagnosis of linear endoscopic ultrasonography and magnifying narrowband endoscopy was compared with the final pathological diagnosis to calculate the diagnostic accuracy of the two methods.

The time from the beginning to the end of examining the invasion depth of early rectal cancer by linear endoscopic ultrasonography or magnifying narrow band endoscopy

Nanfang Hospital, Southern Medical University

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

a TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital.

an endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital.

transanal endoscopic microsurgery

endoscopic submucosal dissection

Stanislav Chernyshov, MD

Transanal endoscopic microsurgery is the main treatment option for rectal tumors such as large adenoma, early cancer because of lower complications and mortality rates and shorter hospital stays rather than conventional surgery. Particularly, However, transanal endoscopic microsurgerymust be performed under either general or spinal anesthesia, and expensive surgical instruments are required. Colorectal endoscopic submucosal dissection is a novel endoscopic procedure that enables en bloc resection of benign colorectal lesions and early colorectal cancer. Endoscopic submucosal dissectioncan be performed under conscious sedation without anesthesia, and there are fewer hospital days than those for transanal endoscopic microsurgery. In the present study, we compared the treatment efficacy and safety between endoscopic submucosal dissectionand transanal endoscopic microsurgery for the treatment of early rectal neoplasms and large rectal adenomas.

Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.

Randomized Controlled Trial of Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment	NCT05927584	Rectal Cancer Rectum Neoplasm	Transanal local...	18 Years -	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Ploidy and Stroma in Early Rectal Cancer	NCT03039595	Rectal Cancer	Ploidy and tumo...	18 Years -	Oxford University Hospitals NHS Trust
The Diagnosis of Invasive Depth of Early Rectal Cancer	NCT04222530	Early Rectal Ca...	Linear EUS firs... ME-NBI first	18 Years - 80 Years	Nanfang Hospital, Southern Medical University
The Diagnosis of Invasive Depth of Early Rectal Cancer	NCT04222530	Early Rectal Ca...	Linear EUS firs... ME-NBI first	18 Years - 80 Years	Nanfang Hospital, Southern Medical University
Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.	NCT03718351	Early Rectal Ca... Large Rectal Ad...	transanal endos... endoscopic subm...	18 Years -	State Scientific Centre of Coloproctology, Russian Federation
Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.	NCT03718351	Early Rectal Ca... Large Rectal Ad...	transanal endos... endoscopic subm...	18 Years -	State Scientific Centre of Coloproctology, Russian Federation
Ploidy and Stroma in Early Rectal Cancer	NCT03039595	Rectal Cancer	Ploidy and tumo...	18 Years -	Oxford University Hospitals NHS Trust

Spots Global Cancer Trial Database for early rectal cancer