Ignite Creation Date:
2024-05-06 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03476434
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2018-03-18
Brief Title:
Chromoendoscopy for Serrated Polyposis Syndrome
Sponsor:
Hospital Universitario de Móstoles
Organization:
Hospital Universitario de Móstoles
Study Overview
Official Title:
Panchromoendoscopy for the Surveillance of Serrated Polyposis Syndrome a Multicenter Prospective and Randomized Trial
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SERRADA
Brief Summary:
Serrated polyposis syndrome SPS is the most common colorectal polyposis syndrome and is characterized by the combination of large andor 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 118-285 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 11 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 cecumileo-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 cecumileo-colonic anastomosis to the rectum followed by a second inspection with panchromoendoscopy For this the lumen was sprayed in a segmental fashion using 04 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
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 11 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 cecumileo-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 cecumileo-colonic anastomosis to the rectum followed by a second inspection with panchromoendoscopy For this the lumen was sprayed in a segmental fashion using 04 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
Detailed Description:
Serrated polyposis syndrome SPS is the most common colorectal polyposis syndrome and is characterized by the combination of large andor 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 118-285 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 11 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 cecumileo-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 cecumileo-colonic anastomosis to the rectum followed by a second inspection with panchromoendoscopy For this the lumen was sprayed in a segmental fashion using 04 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 presenceabsence 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 cancerAll the procedures were done under superficial sedation midazolam andor fentanyl or pethidine or under deep sedation with propofol at the discretion of the endoscopist Procedures were performed with high definition systems ie 180190 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 44004450 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 005 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 150 for windows Numeric variables are presented as mean and standard deviation in case of a normal distribution and compared with a Students 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
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 11 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 cecumileo-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 cecumileo-colonic anastomosis to the rectum followed by a second inspection with panchromoendoscopy For this the lumen was sprayed in a segmental fashion using 04 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 presenceabsence 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 cancerAll the procedures were done under superficial sedation midazolam andor fentanyl or pethidine or under deep sedation with propofol at the discretion of the endoscopist Procedures were performed with high definition systems ie 180190 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 44004450 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 005 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 150 for windows Numeric variables are presented as mean and standard deviation in case of a normal distribution and compared with a Students 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None