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Rate of Cancer of Granular Mixed Laterally Spreading Tumors (GM-LST) (LST GM)

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ClinicalTrials.gov Identifier: NCT03836131
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Brief Summary:

Colorectal cancer (CRC) is the third most common cancer in men and the second in women worldwide, with 1.65 million new cases and almost 835,000 deaths in 2015. CRC is still a major cause of mortality associated with cancer, although the wide spread of the screening program has led to a reduction in the mortality rate compared to the last decades.

CRCs derive from precancerous lesions that may be polypoid or non-polypoid according to the Paris classification. Thus, resection in an early stage could led to a CRC mortality reduction.

Laterally spreading tumors (LST) are non-polypoid lesions of at least 1 cm in diameter that have lateral growth rather than upward or downward growth.

The prevalence of LSTs ranges from 1 to 6% of all colorectal lesions. LSTs can be divided into two groups: granular LSTs, which include homogeneous and granular mixed forms and non-granular (NG) LSTs, which include pseudo-depressed and flat-elevated forms.

Histologically, 90% of LSTs are adenomas and having a low incidence of invasive neoplasia, these lesions can be removed endoscopically.

However, as evidenced by a recent meta-analysis published by Bogie Roel MM et al on Endoscopy, the type of LST and the distal or proximal colonic localization could represent predictors of submucosal invasion and could simplify the therapeutic decision for the removal of these lesions. GM-LSTs and pseudo-depressed NG-LSTs predominantly localize in the distal portion of the colon and have a submucosal invasion rate of 10,5% and 31,6% respectively.

LSTs can be removed both through endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). The main limitation of EMR is that large lesions require a piecemeal approach, resulting in a non-optimal histological evaluation and a high risk of recurrence. ESD instead allows a higher rate of en bloc resections, thus resulting more curative and reducing the risk of having partial and incomplete resections, which can lead to disease recurrence/non curative resection.

LST-GM are characterized by the presence of a granular appearance with a main nodule and represent approximately 1/4 of the LSTs. There are no guidelines indicating the proper resective technique of these lesions.

The European Society of Gastrointestinal Endoscopy (ESGE) suggests to consider ESD for the removal of colorectal lesions that are > 20 mm in size, with a depressed and irregular morphology or a non-granular surface pattern, as these lesions have a high probability of having a limited submucosal invasion. Moreover ESD can be used to treat lesions that cannot be completely removed with standard polypectomy or EMR.

The investigators propose to perform a multicenter retrospective observational study to define the percentage of cancer in patients with GM-LSTs treated with endoscopic resection in order to evaluate the correlation between pre-resection and post-resection characteristics, defining the best therapeutic approach (en bloc or piecemeal) and avoiding incomplete endoscopic resections or unnecessary surgical procedures.


Condition or disease
Colorectal Cancer

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Rate of Cancer of Granular Mixed Laterally Spreading Tumors (GM-LST): A Restrospective Multicentric Analysis
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019



Primary Outcome Measures :
  1. The percentage of cancer in patients with GM-LSTs treated with endoscopic resection. [ Time Frame: 12 Months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This is a multicenter retrospective observational study. All consecutive patients with GM-LST, who underwent endoscopic resection from, will be enrolled in the study.

For each procedure LST size, nodule size, location, type of technique used for removal (EMR, ESD, hybrid ESD), type of removal (piecemeal or en bloc), histological examination, possible surgical intervention (and attached histological examination of the operative piece) and possible relapses will be reported.

Criteria

Inclusion Criteria:

  • Age ≥18 years
  • LST-GM defined according to Paris classification
  • Agree to receive follow up phone calls

Exclusion Criteria:

  • Evidence of familial adenomatous polyposis or inflammatory bowel diseases
  • Deep submucosal invasion diagnosed by distorted pit pattern (Kudo's type V)
  • Poor general clinical condition (American Society of Anesthesiologists score ≥3)
  • Coagulation disorders
  • Pregnancy and breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836131


Contacts
Contact: Alessandro Repici, MD 0039-02-82247493 alessandro.repici@hunimed.eu

Locations
Italy
Humanitas Research Hospital Recruiting
Milano, Italy, 20089
Contact: Alessandro Repici, MD    0039-02-82244507    alessandro.repici@hunimed.eu   
Sponsors and Collaborators
Istituto Clinico Humanitas

Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03836131     History of Changes
Other Study ID Numbers: 767
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases