Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

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

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Intraoperative stereotactic injection of Indigo Carmine

During resection, a small quantity of a special dye called indigo carmine will be infused at the margins of the tumor using computer-guided stereotactic navigation equipment. This dye will be visible during the tumor resection and it can potentially serve as an additional marker of the tumor margins. A post-operative MRI scan -which is part of the standard care- will accurately measure the extent of tumor resection.

Indigo carmine

Theodore Schwartz, MD

The purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.

Low grade gliomas are brain tumors with usually poorly defined borders between tumor and normal brain. This characteristic of low grade gliomas makes the gross total resection of the tumor extremely difficult. Nevertheless, several studies have demonstrated that the risk of recurrence and progression into a more malignant tumor can be decreased with a more aggressive surgical resection. An aggressive attempt to achieve a gross total resection may result in the resection of normal brain and therefore neurological injury. For this reason, the more common error is to subtotally resect the tumor leaving significant volumes of tumor behind. Many techniques have been introduced to safely increase the extent of resection, since the extent of resection is associated with a higher survival rate. Each one of these techniques has several shortcomings. The current study will assess whether the intraoperative stereotactic injection of the indigo carmine at the tumor margins helps to safely increase of extent of tumor resection. In the first step of the study the safety and the correlation between resection of stained tissue/extend of tumor resection will be assessed. If the results are satisfactory, then the second step will ensue. In the second step we will assess the utility of indigo carmine as an additional adjunct to guide tumor resection.

Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection

Evaluation of the extent of resection of the tumor following the indigo carmine infusion to the tumor.

Assessment of Post-operative Clinical Course \& Complications

Weill Medical College of Cornell University

Intraoperative stereotactic injection of Indigo Carmine

Indigo carmine: During resection, a small quantity of a special dye called indigo carmine will be infused at the margins of the tumor using computer-guided stereotactic navigation equipment. This dye will be visible during the tumor resection and it can potentially serve as an additional marker of the tumor margins. A post-operative MRI scan -which is part of the standard care- will accurately measure the extent of tumor resection.

Indigo Carmine

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Tumor Location

Tumor Diagnosis

Information collected from all study participants.

Anita Ou

intraoperative stereotactic injection of indigo carmine at the tumor margins

Extent of Resection

Absence of Complications After Injection

Overall Study

Rectal Neoplasms

Pharmaceutical Solutions

Specimen which underwent pathologic work-up after ex vivo indigo carmine injection into the inferior mesenteric artery after transanal total mesorectal excision.

Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing.

Ex vivo intra-arterial injection of 20 ml indigo carmine solution (10mL, 0.4% indigo carmine with 10mL, 0.9% saline solution) in the transanal total mesorectal excision specimen via the inferior mesenteric artery.

injection of indigo carmine

Walter Brunner, MD MSc MBA

Background: An exact lymph node staging is essential in the treatment of rectal cancer.

Objective: The aim of this study was to assess the effect of indigo carmine injection on the number of retrieved and positive lymph nodes after transanal total mesorectal excision (taTME).

Design: This is a retrospective, non-randomised study. Settings: This study was conducted at a tertiary hospital by a multidisciplinary team.

Patients: Between 2013 and 2019, patients undergoing transanal total mesorectal excision were analysed. Patients with indigo carmine injection (intervention group) were compared to those without (control group).

Interventions: Transanal total mesorectal excision was performed with or without ex vivo intra-arterial indigo carmine injection.

Main Outcome Measures: The number of retrieved and positive lymph nodes was the primary outcome measure.

Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision

number of lymph nodes retrieved by pathologist from the specimen

number of lymph nodes with microscopic tumor infiltration

Walter Brunner

Senior Consultant

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Syndrome

Colorectal Neoplasms, Hereditary Nonpolyposis

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

DNA Repair-Deficiency Disorders

Metabolic Diseases

Colonoscopy with chromoscopy

Christophe CELLIER, Pr,MD,PhD

The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.

Patient with HNPCC syndrome confirmed by a mutation (MLH1, MSH2, MHS1) are involved in the study. Patient have 2 colonoscopy back to back. The second coloscopy is associated to chromoscopy with carmin indigo. Endoscopist are randomised for the colonoscopy with chromoscopy and are un-awarded of the result of the first colonoscopy. Histopathology of the polyp are noted. The follow up were 1 month.

CHROENDOHNPCC: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer Syndrome

Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Syndrome: Assessment of Coloscopy With Chromoscopy Benefit

Assistance Publique - Hôpitaux de Paris

Saliha DJANE

Colonic Neoplasms

Colonic Polyps

Polyps

Pathological Conditions, Anatomical

Intestinal Polyps

Herbal and Botanical

Cola

Two tandem colonoscopies: first inspection was on high-resolution white-light endoscopy from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection also on HR-WLE.

two tandem colonoscopies: first inspection was on HR-WLE from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection with panchromoendoscopy on indigo carmine.

the lumen of the colon is sprayed in a segmental fashion using 0.4% indigo carmine delivered via a specially designed dye spray catheter (Olympus PW-5V1) or via the accessory channel with a 50cc syringe filled with indigo carmine and air.

chromoendoscopy with indigo carmine

Jorge Lopez Vicente

Serrated polyposis syndrome (SPS) is the most common colorectal polyposis syndrome and is characterized by the combination of large and/or numerous serrated lesions (SLs) throughout the colorectum. SLs are classified into sessile serrated polyps (SSP) with or without dysplasia, hyperplastic polyps (HP) and traditional serrated adenomas (TSA). In 2010 the World Health Organization (WHO) defined this syndrome by any one of the following conditions: criterion I, at least 5 SLs proximal to the sigmoid colon with 2 or more of these being \>10mm in size; criterion II, any SLs proximal to the sigmoid colon in a first-degree relative with SPS; criterion III, more than 20 SLs of any size distributed throughout the colon. It has been demonstrated that 11.8-28.5% of patients with SPS present with colorectal cancer (CRC) at diagnosis. Tandem colonoscopy studies have demonstrated that a significant number of lesions are missed during conventional colonoscopy. This finding is even more evident when focusing SLs where a 31% miss rate has been reported. SLs are often overlooked due to their typical appearance: flat morphology, similar colour to the surrounding mucosa, subtle and indistinctive borders. Chromoendoscopy (dye spraying onto the surface of the colon) enhances the detection of subtle and flat polyps in the colon. Until the date no studies have assessed the use of dye-based chromoendoscopy in SPS patients.

The aim of this trial was to evaluate the usefulness of panchromoendoscopy with indigo carmine for the detection of polyps in the colon in patients with SPS. Secondary aims were to estimate the SLs and adenoma miss rates in these patients.

Patients were randomized in a 1:1 distribution to one of the two arms of the study by a list of random numbers distributed by the coordinator center. After randomization, patients were submitted to tandem colonoscopies by the same endoscopist:

* In group A (HR-WLE) the first inspection was on high-resolution white-light endoscopy from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection also on HR-WLE.
* In group B (HR-CE) the first inspection was on HR-WLE from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection with panchromoendoscopy. For this, the lumen was sprayed in a segmental fashion using 0.4% indigo carmine delivered via a specially designed dye spray catheter (Olympus PW-5V1) or via the accessory channel with a 50cc syringe filled with indigo carmine and air. After allowing a few seconds for the dye to settle onto the mucosal surface, excess pools of indigo carmine were suctioned and the mucosa was then scrutinised.

Time to withdrawal from the cecum was measured using a stopwatch excluding time needed for polypectomy and biopsies.

Lesions detected during each inspection were described and then removed. Size (measured in comparison with an open biopsy forceps), morphology (using the Paris classification), location and polypectomy technique were recorded before removal. Histology was used as gold standard.

Serrated polyposis syndrome (SPS) is the most common colorectal polyposis syndrome and is characterized by the combination of large and/or numerous serrated lesions (SLs) throughout the colorectum. SLs are classified into sessile serrated polyps (SSP) with or without dysplasia, hyperplastic polyps (HP) and traditional serrated adenomas (TSA). In 2010 the World Health Organization (WHO) defined this syndrome by any one of the following conditions: criterion I, at least 5 SLs proximal to the sigmoid colon with 2 or more of these being \>10mm in size; criterion II, any SLs proximal to the sigmoid colon in a first-degree relative with SPS; criterion III, more than 20 SLs of any size distributed throughout the colon. It has been demonstrated that 11.8-28.5% of patients with SPS present with colorectal cancer (CRC) at diagnosis. Tandem colonoscopy studies have demonstrated that a significant number of lesions are missed during conventional colonoscopy. This finding is even more evident when focusing SLs where a 31% miss rate has been reported. SLs are often overlooked due to their typical appearance: flat morphology, similar colour to the surrounding mucosa, subtle and indistinctive borders. Chromoendoscopy (dye spraying onto the surface of the colon) enhances the detection of subtle and flat polyps in the colon. Until the date no studies have assessed the use of dye-based chromoendoscopy in SPS patients.

The aim of this trial was to evaluate the usefulness of panchromoendoscopy with indigo carmine for the detection of polyps in the colon in patients with SPS. Secondary aims were to estimate the SLs and adenoma miss rates in these patients.

Patients were randomized in a 1:1 distribution to one of the two arms of the study by a list of random numbers distributed by the coordinator center. After randomization, patients were submitted to tandem colonoscopies by the same endoscopist:

* In group A (HR-WLE) the first inspection was on high-resolution white-light endoscopy from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection also on HR-WLE.
* In group B (HR-CE) the first inspection was on HR-WLE from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection with panchromoendoscopy. For this, the lumen was sprayed in a segmental fashion using 0.4% indigo carmine delivered via a specially designed dye spray catheter (Olympus PW-5V1) or via the accessory channel with a 50cc syringe filled with indigo carmine and air. After allowing a few seconds for the dye to settle onto the mucosal surface, excess pools of indigo carmine were suctioned and the mucosa was then scrutinised.

Time to withdrawal from the cecum was measured using a stopwatch excluding time needed for polypectomy and biopsies.

Lesions detected during each inspection were described and then removed. Size (measured in comparison with an open biopsy forceps), morphology (using the Paris classification), location and polypectomy technique were recorded before removal. Histology was used as gold standard. Biopsies were processed and stained using standard methods, and were subsequently evaluated by experienced gastrointestinal pathologists in each center according to Vienna criteria of gastrointestinal epithelial neoplasia. Serrated lesions were classified according to the WHO 2010 classification into hyperplastic polyps, sessile serrated polyps, and traditional serrated adenomas. Cytological dysplasia among serrated polyps was analyzed both as presence/absence of dysplasia, as well as the presence of low-grade and high-grade dysplasia. Neoplastic extension vertically into the submucosal layer or beyond was classified as invasive cancer.All the procedures were done under superficial sedation (midazolam and/or fentanyl or pethidine) or under deep sedation with propofol at the discretion of the endoscopist. Procedures were performed with high definition systems \[i.e: 180/190 series in combination with EVIS EXERA II-III processors (Olympus, Tokyo, Japan), EC 390 LI scope in combination with Pentax processor (Pentax, Tokyo, Japan) or 590 WL and 580 ZW endoscopes in combination with Fujinon 4400/4450 processors (Fujifilm medical systems, USA)\].

Quality of bowel cleansing was graded by each endoscopist following the Boston Bowel Preparation Scale. Adequate preparation was defined as a total score ≥6 with no segments \<2. Procedures in which the quality of preparation was inadequate were excluded.

Sample size calculation: a polyp miss rate of 29% with HR-WLE was described previously in a Dutch multicenter study with SPS patients. Estimating a power of 80% and a significance level of 0.05, the investigators calculated 516 lesions would be required to measure a difference of 15% on HR-CE. In a previous study a median of 6 polyps was found on annual surveillance4. The investigators calculated a simple size of 86 patients for the study, 43 on each group.

Statistical analysis was performed with SPSS version 15.0 for windows. Numeric variables are presented as mean and standard deviation in case of a normal distribution and compared with a Student´s t test. Categorical variables are presented as frequencies and compared with the Chi Square test. Polyp miss rates were compared with chi square test. Logistic regression analysis was used to compare polyp characteristics and miss rates and was expressed as Odds ratio with the confidence intervals (95% CIs) to quantify the magnitude of the associations.

Patients are randomized into two groups with tandem explorations: in the group A or white light group (HR-WLE) where inspection is performed with white light in both colonoscopies, and in the group B or chromoendoscopy group (HR-CE) where a first inspection is performed with white light and the second with panchromoendoscopy with indigo carmine.

Chromoendoscopy for Serrated Polyposis Syndrome

Panchromoendoscopy for the Surveillance of Serrated Polyposis Syndrome, a Multicenter, Prospective and Randomized Trial.

number of polyps detected during the second inspection divided by the total number of polyps detected during the first and the second examination

number of serrated lesions detected during the second inspection divided by the total number of serrated lesions detected during the first and the second examination

number of adenomas detected during the second inspection divided by the total number of adenomas detected during the first and the second examination

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions	NCT01521091	Colorectal Neop...		18 Years - 90 Years	Shanghai Jiao Tong University School of Medicine
Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection	NCT01767415	Brain Tumors Wi...	Indigo carmine	18 Years - 65 Years	Weill Medical College of Cornell University
Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision	NCT04455737	Rectal Neoplasm...	injection of in...	18 Years -	Cantonal Hospital of St. Gallen
CHROENDOHNPCC: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer Syndrome	NCT00224601	Colorectal Neop...	Colonoscopy wit...	25 Years - 75 Years	Assistance Publique - Hôpitaux de Paris
CHROENDOHNPCC: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer Syndrome	NCT00224601	Colorectal Neop...	Colonoscopy wit...	25 Years - 75 Years	Assistance Publique - Hôpitaux de Paris
Chromoendoscopy for Serrated Polyposis Syndrome	NCT03476434	Colonic Polyp Colonic Neoplas... Colonic Cancer	chromoendoscopy...	18 Years - 90 Years	Hospital Universitario de Móstoles
Chromoendoscopy for Serrated Polyposis Syndrome	NCT03476434	Colonic Polyp Colonic Neoplas... Colonic Cancer	chromoendoscopy...	18 Years - 90 Years	Hospital Universitario de Móstoles
CHROENDOHNPCC: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer Syndrome	NCT00224601	Colorectal Neop...	Colonoscopy wit...	25 Years - 75 Years	Assistance Publique - Hôpitaux de Paris

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