Ignite Creation Date:
2024-05-06 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03498664
Status:
UNKNOWN
Last Update Posted:
2019-01-11
First Post:
2018-04-07
Brief Title:
EMR-C VS EMR-S in Colonic Lateral Spreading Tumors Treatment LST
Sponsor:
Azienda Ospedaliera Universitaria Senese
Organization:
Azienda Ospedaliera Universitaria Senese
Study Overview
Official Title:
Cap-assisted Endoscopic Mucosal Resection vs Standard Inject and Cut Endoscopic Mucosal Resection for Large Colonic Lateral Spreading Tumors Treatment a Randomized Multicentric Study
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
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:
LST
Brief Summary:
Lateral Spreading Tumors LSTs are dysplastic lesions whose protrusion within the lumens the colon is not more than twice as compared to the surrounding non-dysplastic mucosa
They can be divided into two groups
Granular type LST-G and Non Granular type LST-NG Endoscopic mucosal resection EMR and endoscopic submucosal dissection ESD are currently the most used techniques to resect this type of lesions Compared to other methods of tissue ablation EMR allows to carry out the histological evaluation of the resected fragments and ESD of the lesion in toto en bloc EMR is currently the most used technique for removal of LST but for lesions of 30 mm the resection is performed piecemeal ie fragmentary This can compromise an adequate histological evaluation of the lateral and deep margins of the lesion
Colonic EMR EMR-S is usually performed using a polypectomy snare after lifting the lesion from the underlying layers with a submucosal injection of liquid EMR standard or inject-and-cut The aspiration of the lesion inside a plastic cap preloaded on the tip of the colonoscope cap-assisted EMR - EMR-C is almost exclusively used for the treatment of gastric and esophageal lesions Its use for lesions of the colon and duodenum has been reported in limited experiences The principal aim of this study is to evaluate the efficacy and the safety of the EMR-C for the removal of large colonic LST-G and LST-NG comparing it with EMR-S
They can be divided into two groups
Granular type LST-G and Non Granular type LST-NG Endoscopic mucosal resection EMR and endoscopic submucosal dissection ESD are currently the most used techniques to resect this type of lesions Compared to other methods of tissue ablation EMR allows to carry out the histological evaluation of the resected fragments and ESD of the lesion in toto en bloc EMR is currently the most used technique for removal of LST but for lesions of 30 mm the resection is performed piecemeal ie fragmentary This can compromise an adequate histological evaluation of the lateral and deep margins of the lesion
Colonic EMR EMR-S is usually performed using a polypectomy snare after lifting the lesion from the underlying layers with a submucosal injection of liquid EMR standard or inject-and-cut The aspiration of the lesion inside a plastic cap preloaded on the tip of the colonoscope cap-assisted EMR - EMR-C is almost exclusively used for the treatment of gastric and esophageal lesions Its use for lesions of the colon and duodenum has been reported in limited experiences The principal aim of this study is to evaluate the efficacy and the safety of the EMR-C for the removal of large colonic LST-G and LST-NG comparing it with EMR-S
Detailed Description:
Colorectal carcinoma CRC is the second cause of death for cancer in industrialized countries with annual incidence and mortality of about one million and 500000 case respectively
Its well known that most of CRC follow the path adenoma-carcinoma early diagnosis and endoscopic removal of colonic polyps has been proved to be useful in preventing cancer
Most of colorectal polyps are smaller than 1 cm and can be successfully resected with a standard polypectomy However between 08 and 5 of patients develop sessile polyps or lesions larger than 20 mm of which removal can be difficult requiring high endoscopic experience
Recent prospective studies report that 7-36 of CRC have a flat or depressed morphology and are more likely to infiltrate the submucosa compared with polypoid ones
A univariate analysis has proved that the size of the lesion is the only significant risk factor associated with malignant evolution
Contrary to sessile polyps SP that are protruding lesions without a peduncle and whose base has almost the same dimension of the head Lateral Spreading Tumors LSTs are dysplastic lesions whose protrusion within the lumen is not more than twice as compared to the surrounding non-dysplastic mucosa According to Kudo classification they are larger than 1 cm in size slightly elevated and extending laterally along the intestinal wall
They can be divided into two groups according to Paris Classification 2005 updated for the colon in Kyoto Classification 2008
Granular type LST-G characterized by nodular aggregates and sub-classified into homogeneous 0-IIa according to Paris Classification and mixed nodular 0-IIa 0-Is IIa 0-II Is subtypes
Non Granular type LST-NG characterized by a non nodular surface and sub-classified into elevated 0-IIa and pseudo-depressed 0-IIa 0-IIc 0-IIc 0- IIa subtypes
The risk of developing cancer is different between the two types 577 in LST-NG vs 327 in LST-G LST-NG are more likely to invade the submucosa compared to LST-G 14 vs 7 Within the LST-G group lesions with a mixed nodular morphology have a greater tendency to infiltrate the submucosa compared to the homogeneous ones
Endoscopic mucosal resection EMR and endoscopic submucosal dissection ESD are currently the most used techniques to resect this type of lesions Compared to other methods of tissue ablation EMR allows to carry out the histological evaluation of the resected fragments and ESD of the lesion in toto en bloc
EMR allows the resection of superficial neoplasia of gastro-intestinal tract GI confined to the mucosa in the absence of vascular andor lymphatic invasion
ESD compared with EMR allows to remove en bloc lesions 20 mm in size It should be preferred for lesions with higher risk of invasiveness or when the removal of the deepest layers or of the whole submucosa is desired despite the size of the lesion However ESD is a complex procedure which requires a long training period and it is associated with higher risk of perforation compared with EMR 62 vs 13 Furthermore ESD requires a longer execution time
Therefore EMR is currently the most used technique for removal of LST but for lesions of 30 mm the resection is performed piecemeal ie fragmentary This can compromise an adequate histological evaluation of the lateral and deep margins of the lesion
Piecemeal resection increases the risk of residual disease that ranges from 12 to 20 compared with 5 described after en bloc removal while the percentage of recurrence reported for polypoid lesions 20 mm is on average 25 21 and reaches 55 in some studies
Colonic EMR is usually performed using a polypectomy snare after lifting the lesion from the underlying layers with a submucosal injection of liquid EMR standard or inject-and-cut The aspiration of the lesion inside a plastic cap preloaded on the tip of the colonoscope cap-assisted EMR - EMR-C is almost exclusively used for the treatment of gastric and esophageal lesions Its use for lesions of the colon and duodenum has been reported in limited experiences
The advantage of diagnostic cap-assisted colonoscopy CAC is the higher chance of reaching cecum even by less experienced endoscopists in a shorter time with less pain for the patients and a better observation of the mucosa behind the folds and at the flexures There are not enough concordant data about the percentage of missing lesions especially if small in size 27 28 The cap makes the position of the instrument more stable during standard inject-and-cut technique EMR-S and reduces execution time However the realization of the EMR-C for colonic lesions isnt reported 29
The use of EMR-C in colon is controversial because of the risk of entrapping the muscular layer in the polypectomy snare with risk of perforation
The advantage of using the cap is represented by the possibility to perform mucosectomy of lesions located in difficult positions between haustra near or involving the ileo-caecal valve thanks to the improved visibility on the operative field
Our group has reported a 4 of residual diseaserecurrence rate much lower than those reported by other authors who performed EMR-S We had a perforation and bleeding rate of 0 and 7 respectively vs 04 and 11 as reported in literature with EMR-S
More recently a study of 134 lesions treated with EMR-C reported a recurrence rate of 18 on 82 lesions treated with a mean of 42 months follow-up
The principal aim of this study is to evaluate the efficacy and the safety of the EMR-C for the removal of large colonic granular and non-granular Lateral Spreading Tumors LST-G LST-NG comparing it with EMR-S
Patients with colorectal LST-GNG 30 mm will be included Patients who refuse endoscopic follow up will be excluded from the study The total enrollment period will be 6 months Endoscopic evaluation in patients without invasive carcinoma will be performed at 3 6 and 12 months and then annually Follow-up period will last 12 months from the enrollment of the last patient
Will be defined as
Residual lesion the presence of adenomatous tissue endoscopically visible at follow-up colonoscopies within the first year from EMR
Recurrent lesion the presence of adenomatous tissue endoscopically visible after 2 at 3 and 6 months from EMR previous negative colonoscopies
Its well known that most of CRC follow the path adenoma-carcinoma early diagnosis and endoscopic removal of colonic polyps has been proved to be useful in preventing cancer
Most of colorectal polyps are smaller than 1 cm and can be successfully resected with a standard polypectomy However between 08 and 5 of patients develop sessile polyps or lesions larger than 20 mm of which removal can be difficult requiring high endoscopic experience
Recent prospective studies report that 7-36 of CRC have a flat or depressed morphology and are more likely to infiltrate the submucosa compared with polypoid ones
A univariate analysis has proved that the size of the lesion is the only significant risk factor associated with malignant evolution
Contrary to sessile polyps SP that are protruding lesions without a peduncle and whose base has almost the same dimension of the head Lateral Spreading Tumors LSTs are dysplastic lesions whose protrusion within the lumen is not more than twice as compared to the surrounding non-dysplastic mucosa According to Kudo classification they are larger than 1 cm in size slightly elevated and extending laterally along the intestinal wall
They can be divided into two groups according to Paris Classification 2005 updated for the colon in Kyoto Classification 2008
Granular type LST-G characterized by nodular aggregates and sub-classified into homogeneous 0-IIa according to Paris Classification and mixed nodular 0-IIa 0-Is IIa 0-II Is subtypes
Non Granular type LST-NG characterized by a non nodular surface and sub-classified into elevated 0-IIa and pseudo-depressed 0-IIa 0-IIc 0-IIc 0- IIa subtypes
The risk of developing cancer is different between the two types 577 in LST-NG vs 327 in LST-G LST-NG are more likely to invade the submucosa compared to LST-G 14 vs 7 Within the LST-G group lesions with a mixed nodular morphology have a greater tendency to infiltrate the submucosa compared to the homogeneous ones
Endoscopic mucosal resection EMR and endoscopic submucosal dissection ESD are currently the most used techniques to resect this type of lesions Compared to other methods of tissue ablation EMR allows to carry out the histological evaluation of the resected fragments and ESD of the lesion in toto en bloc
EMR allows the resection of superficial neoplasia of gastro-intestinal tract GI confined to the mucosa in the absence of vascular andor lymphatic invasion
ESD compared with EMR allows to remove en bloc lesions 20 mm in size It should be preferred for lesions with higher risk of invasiveness or when the removal of the deepest layers or of the whole submucosa is desired despite the size of the lesion However ESD is a complex procedure which requires a long training period and it is associated with higher risk of perforation compared with EMR 62 vs 13 Furthermore ESD requires a longer execution time
Therefore EMR is currently the most used technique for removal of LST but for lesions of 30 mm the resection is performed piecemeal ie fragmentary This can compromise an adequate histological evaluation of the lateral and deep margins of the lesion
Piecemeal resection increases the risk of residual disease that ranges from 12 to 20 compared with 5 described after en bloc removal while the percentage of recurrence reported for polypoid lesions 20 mm is on average 25 21 and reaches 55 in some studies
Colonic EMR is usually performed using a polypectomy snare after lifting the lesion from the underlying layers with a submucosal injection of liquid EMR standard or inject-and-cut The aspiration of the lesion inside a plastic cap preloaded on the tip of the colonoscope cap-assisted EMR - EMR-C is almost exclusively used for the treatment of gastric and esophageal lesions Its use for lesions of the colon and duodenum has been reported in limited experiences
The advantage of diagnostic cap-assisted colonoscopy CAC is the higher chance of reaching cecum even by less experienced endoscopists in a shorter time with less pain for the patients and a better observation of the mucosa behind the folds and at the flexures There are not enough concordant data about the percentage of missing lesions especially if small in size 27 28 The cap makes the position of the instrument more stable during standard inject-and-cut technique EMR-S and reduces execution time However the realization of the EMR-C for colonic lesions isnt reported 29
The use of EMR-C in colon is controversial because of the risk of entrapping the muscular layer in the polypectomy snare with risk of perforation
The advantage of using the cap is represented by the possibility to perform mucosectomy of lesions located in difficult positions between haustra near or involving the ileo-caecal valve thanks to the improved visibility on the operative field
Our group has reported a 4 of residual diseaserecurrence rate much lower than those reported by other authors who performed EMR-S We had a perforation and bleeding rate of 0 and 7 respectively vs 04 and 11 as reported in literature with EMR-S
More recently a study of 134 lesions treated with EMR-C reported a recurrence rate of 18 on 82 lesions treated with a mean of 42 months follow-up
The principal aim of this study is to evaluate the efficacy and the safety of the EMR-C for the removal of large colonic granular and non-granular Lateral Spreading Tumors LST-G LST-NG comparing it with EMR-S
Patients with colorectal LST-GNG 30 mm will be included Patients who refuse endoscopic follow up will be excluded from the study The total enrollment period will be 6 months Endoscopic evaluation in patients without invasive carcinoma will be performed at 3 6 and 12 months and then annually Follow-up period will last 12 months from the enrollment of the last patient
Will be defined as
Residual lesion the presence of adenomatous tissue endoscopically visible at follow-up colonoscopies within the first year from EMR
Recurrent lesion the presence of adenomatous tissue endoscopically visible after 2 at 3 and 6 months from EMR previous negative colonoscopies
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