Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Cicatrix

Neoplasm Recurrence, Local

Disease Attributes

Neoplastic Processes

EMR scar is interrogated using WLE followed by NBI

EMR scar is interrogated using NBI followed by WLE

EMR scar is inspected using WLE followed by NBI or vice versa

WLE followed by NBI or NBI followed by WLE (crossover design)

Miguel Areia, PhD

Nowadays endoscopic mucosal resection (EMR) is the gold standard for the removal of large laterally spreading and sessile colorectal lesions ≥ 20 mm. However, recurrence rate after successful EMR (defined by the absence of neoplastic tissue at the completion of the procedure after careful inspection of the post-EMR mucosal defect and margin) is about 15-20%. Consequently, current guidelines recommend a surveillance colonoscopy between 4 and 6 months after resection for detection of residual or recurrent polyp.

There are few studies that have examined the accuracy of advanced endoscopic imaging for the prediction of histological recurrence but none of these imaging modalities have been validated for surveillance after EMR. Therefore, current guidelines strongly recommend systematic biopsy of EMR scar.

The main aim of this study is to assess the incremental benefit of narrow band imaging (NBI) and white light endoscopy (WLE) randomizing the initial technique for the endoscopic detection of post-EMR recurrence and to asses if this advanced imaging method achieve sufficient diagnostic accuracy to exclude recurrence without the need for biopsy.

a. Study type: multicenter randomized crossover trial: i. prospective inclusion of consecutive patients undergoing first follow-up surveillance colonoscopy after successful EMR of colorectal lesion; ii. crossover randomization by computer generated tables; iii. allocation concealment by sealed, opaque envelopes; iv. pathologist-blinded - pathologists are blinded to the study protocol and samples are received as 'EMR scar for assessment' .

b. Selection patient method: inclusion by invitation of patients undergoing the first follow-up surveillance colonoscopy after successful EMR of colorectal lesion.

c. Sample size: 210 (two groups of 105 patients). To improve accuracy from 85% (value obtained by a study that did not show significant differences in the accuracy of NBI followed by WLE vs. WLE followed by NBI) to 95% and assuming a normal distribution and a power of 80% (α=0.05), the calculated sample size of each of the 2 groups was 96; allowing for a 10% dropout rate, the sample size is 105 per group (210 patients overall).

d. Procedures and data collection methods: i. Each procedure is performed by the same endoscopist. ii. All patients receive split dose bowel preparation. iii. All colonoscopies are performed using high definition colonoscopes with NBI ( EVIS EXERA III CV 185 and CV 190; Olympus Inc., Tokyo, Japan). iv. Colon inspection is done with WLE during withdrawal. v. At the proximity of the scar WLE and NBI were used randomly one after the other (WLE\>NBI or NBI\>WLE). If NBI is the first technique used, it is switched prior to scar detection, avoiding, as far as possible, a glance with WLE. The edges of the scar are interrogated followed by the centre of the scar and finding are recorded. vi. After both evaluations, if there is no suspicion of recurrence, the site is sampled by at least 2 biopsies of the scar edge. If there is any suspicion of recurrence, tissue sample is obtained and then treated by endoscopic resection using standard methods. At least 2 biopsies specimens from normal appearing scar are also obtained.

e. Analysed variables: i. patient characteristics; ii. data from baseline colonoscopy; iii. data from first surveillance colonoscopy (see outcome measures).

f. Statistical analysis: i. Performed using statistical software IBM SPSS Statistics, Version 25.0. Armonk, NY: IBM Corp. ii. Continuous variables are reported as mean and standard deviation or median and interquartile range, if they have normal or not normal distribution, respectively; categorical variables as absolute and relative frequency. iii. Continuous variables are compared between two groups using Student's T test if they have a normal distribution and homogeneity of variance or Mann-Whitney U if these conditions are not met. Categorical variables are compared using Pearson's X2 test or Fisher test. iv. Sensitivity, specificity, negative and positive predictive values and accuracy are calculated using 2x2 contingency tables. v. All hypotheses are two-tailed and a P-value\<0.05 is considered statistically significant.

Follow-up Protocol of Colorectal Endoscopic Mucosal Resection Scars

Follow-up Protocol of Colorectal Endoscopic Mucosal Resection Scars: a Multicentre Randomized Single-blinded Crossover Trial

Sensitivity, specificity, negative predictive value, positive predictive value and accuracy of NBI and WLE for each group calculated using 2x2 contingency tables

WLE recurrent adenoma identification for each group

NBI recurrent adenoma identification for each group

Adenoma recurrence confirmed by histology

Lesion size and location, Paris classification, NICE classification, number of pieces, use of adjunctive ablative techniques and those identification and histology. Data collected by endoscopic reports consultation

Scar size, presence or absence of recurrence, in case of recurrence: number of sites, location (edge of the scar, within the scar or both), morphology of recurrence, NICE classification (for NBI evaluation)

Portuguese Oncology Institute, Coimbra

Medical Doctor

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Micronutrients

Antineoplastic Agents

Vitamins

Bupivacaine

Anesthetics

Sufentanil

Dsuvia

Vitamin A

Retinol palmitate

Retinol

We collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA.

SA was carried out in a sitting position, following a strictly aseptic technique. After recognition of L2-L3 intervertebral space through landmark technique, a 25 Gauge needle was inserted and the correct positioning was confirmed by detecting free flow of cerebrospinal fluid. Subsequently, 10-12 mg of hyperbaric bupivacaine + sufentanil 2 mcg according to the decision of the anesthetist was administered intrathecally without barbotage.

Subsequently, the patient underwent ESD of the colorectal lesion.

endoscopic submucosal dissection of large colorectal lesions under spinal anesthesia

ESD of large LSTs under SA

Mauro Manno, MD

The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS).

Background and study aim: Endoscopic submucosal dissection (ESD) of large colorectal lesions requires the patient to be in a still position for a long time. Both deep sedation and general anesthesia carry a substantial risk of anesthesia-related adverse events (ARAEs), especially in frail patients. Conversely, mild-to-moderate sedation does not prevent involuntary movements of the patient. Spinal anesthesia (SA) is a safe and simple technique that provides analgesia and motor block without systemic drug administration or orotracheal intubation. As the use of SA in colorectal endoscopic resections has not been described so far, we aimed to evaluate the feasibility and performance of SA in large (\>35 mm) recto-sigmoid lesion ESD.

Patients and methods: The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS). The secondary endpoints were as follows: intra- and post-procedural need for additional opioid or other analgesic drug administration, ESD-related adverse eventss, length of hospital stay, and median ESD duration.

Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia

Technical success was defined as completion of the ESD under SA without the need of conversion to deep sedation or general anesthesia.

Safety was evaluated intra- and post-procedurally by recording anesthesia-related adverse events (ARAEs). Major ARAEs included death, anaphylaxis and severe cardiorespiratory or neurologic AEs. Minor ARAEs included any other cardiorespiratory or neurologic AEs, headache, acute urinary retention and itching.

Intra- and post-procedural need for additional opioid or other analgesic drug administration

Perforation, bleeding, post-coagulation syndrome, adverse events related to endoscopic bowel preparation

Azienda USL Modena

Directore Gastroenterology and Endoscopy Unit

Anti-Infective Agents

Acetic Acid

Retinol acetate

Xiaobo Li, MD. Ph.D

Chromoendoscopy (indigo carmine or acetic acid) and Narrow Band Imaging (NBI) could make accurate evaluation in predicting of invasive depth of colorectal neoplasia. NBI could be the first choice.

To compare the diagnostic accuracy of chromoendoscopy indigo carmine or acetic acid and NBI for differentiating neoplastic from non-neoplastic colorectal lesions, differentiating adenomas from carcinomas, and differentiating early carcinomas from invasive ones.

Included colorectal lesions consecutively distribute in a 1:1 ratio to 2 groups.

All the lesions will be removed endoscopically or surgically and examine histologically by an independent gastrointestinal pathologist.

Histological diagnosis is determined according to the World Health Organization (WHO) criteria. Pedunculated lesions are categorized according to Haggitt's classification.

Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions

Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions Using Magnifying Colonoscopy With Narrow Band Imaging, Indigo Carmine, and Acetic Acid Staining

Shanghai Jiao Tong University School of Medicine

Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine

Magnification narrow band imaging (NBI) can make accurate evaluation in in predicting of invasive depth of colorectal neoplasia.

NBI could be used in stratifying patients for endoscopic resection or surgery and got an accurate evaluation.

All the lesions will be removed endoscopically or surgically and examined histologically by an independent gastrointestinal pathologist.

Histological diagnosis is determined according to the World Health Organization (WHO) criteria.Pedunculated lesions are categorized according to Haggitt's classification.

The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery

The Value of NBI in Stratifying Patients for Endoscopic Resection or Surgery

Hemorrhage

Coagulants

Hemostatics

To compare of the risk of bleeding after endoscopic submucosal dissection, after ESD, application of Purastat gel (not a drug but a device with CE mark) with a catheter of a gel on the resected area to cover the whole surface of mucosal resection.

After endoscopic submucosal dissection (ESD) and hemostasis, if the patient is randomized in the comparative group, no gel will be applied on the resected area that will remain like this without intervention (common practice)

Endoscopic submucosal dissection with Purastat

Mathieu PIOCHE, Pr

Mathieu PIOCHE, PI

The problem of delayed bleeding after endoscopic resection is becoming important due to the growing number of indications for anti-aggregation or anticoagulant treatment for cardiovascular reasons in the aging populations. Previous studies have shown that in patients at high risk of bleeding, the use of (PuraStat®), a simple and easily applicable solution, decreases the rate of delayed bleeding by promoting wound healing. Various preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. The main objective is to compare the efficacy of PuraStat® to the standard treatment in reducing delayed bleeding after colorectal ESD in patients at high risk of delayed bleeding. The secondary objectives are to compare the same two strategies in terms of effectiveness and side effects. The primary outcome measure is the percentage of delayed bleeding at 30 days after surgery (ESD).

Efficacy of a Hemostatic Agent (PuraStat®) in Reducing Delayed Bleeding After Endoscopic Submucosal Dissection

A Multicenter Randomized Controlled Trial to Evaluate the Efficacy of a Hemostatic Agent (PuraStat®) in Reducing Delayed Bleeding After Endoscopic Colorectal Submucosal Dissection

Percentage of delayed bleeding is expressed primarily by the number of patients with at least one unplanned colorectal endoscopy occurring within 30 days of surgery (ESD)

Number of patients with at least one unplanned colorectal endoscopy by factors for secondary bleeding occurring within 30 days of ESD.

Number of patients requiring hemostasis, unplanned occurring within 30 days of ESD.

Number of patients for whom at least one transfusion was ordered after the ESD

Number of patients with at least one delayed perforation or one symptomatic stenosis.

Number of hospitalizations and number of days of hospitalization per stay within 30 days after ESD

Number of patients with at least one irritation or thromboembolic accidents.

Time between introduction and removal of the PuraStat® catheter.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Follow-up Protocol of Colorectal Endoscopic Mucosal Resection Scars	NCT04239365	Colorectal Canc... Recurrence, Loc...	WLE followed by...	18 Years -	Portuguese Oncology Institute, Coimbra
Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia	NCT06316401	Colorectal (Col...	ESD of large LS...	18 Years -	Azienda USL Modena
Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions	NCT01521091	Colorectal Neop...		18 Years - 90 Years	Shanghai Jiao Tong University School of Medicine
Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia	NCT06316401	Colorectal (Col...	ESD of large LS...	18 Years -	Azienda USL Modena
Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia	NCT06316401	Colorectal (Col...	ESD of large LS...	18 Years -	Azienda USL Modena
The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery	NCT01521104	Colorectal Neop...		18 Years - 90 Years	Shanghai Jiao Tong University School of Medicine
The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery	NCT01521104	Colorectal Neop...		18 Years - 90 Years	Shanghai Jiao Tong University School of Medicine
Efficacy of a Hemostatic Agent (PuraStat®) in Reducing Delayed Bleeding After Endoscopic Submucosal Dissection	NCT05031325	Colo-rectal Can...	Endoscopic subm...	18 Years - 90 Years	Société Française d'Endoscopie Digestive
The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery	NCT01521104	Colorectal Neop...		18 Years - 90 Years	Shanghai Jiao Tong University School of Medicine
The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery	NCT01521104	Colorectal Neop...		18 Years - 90 Years	Shanghai Jiao Tong University School of Medicine
Efficacy of a Hemostatic Agent (PuraStat®) in Reducing Delayed Bleeding After Endoscopic Submucosal Dissection	NCT05031325	Colo-rectal Can...	Endoscopic subm...	18 Years - 90 Years	Société Française d'Endoscopie Digestive

Spots Global Cancer Trial Database for colorectal lesions