Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04512729 |
| Other study ID # |
DoCPI |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 4, 2020 |
| Est. completion date |
December 30, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Asian Institute of Gastroenterology, India |
| Contact |
D Nageshwar Reddy, MD,DM |
| Phone |
914023378888 |
| Email |
aigindia[@]yahoo.co.in |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Colorectal carcinoma (CRC) is the third most common cancer in male and female worldwide. In
India, it is the fourth most common cause of cancer in males and third most common cancer in
female. Age, smoking, colonic adenomatous polyp, family history are traditional risk factor
for CRC. The vast majority of CRC results from malignant transformation from adenoma, which
is called as adenoma carcinoma sequence. These adenomatous polyps grows slowly over many
years and malignant transformation eventually occurs over 10 years. So, the early detection
and removal of polyp at early stage should benefit in preventing CRC.
Description:
The third most common cancer in both male and female is colorectal carcinoma (CRC) worldwide.
In India, it is the fourth most common cause of cancer in males and third most common cancer
in females. The age - standardized rates of CRC in India have been estimated to be 4.2 and
3.2/100000 for males and females, respectively. Age, smoking and colonic adenoma along with
family history is considered as traditional risk factors for CRC. The US National Polyp study
demonstrated that colonoscopy and polypectomy could prevent 76% to 90% of colorectal cancers.
The vast majority of CRC result from malignant transformation from adenomas. This is called
adenoma - carcinoma sequence, these adenomatous polyps grows slowly over many years and
malignant transformation eventually occurs. The time span for this transformation is on an
average 10 years. So, the detection and removal of polyp at early stage on adenoma -
carcinoma sequence should benefit in preventing CRC.
The prevalence of adenoma, utilization of colonoscopy for its detection and subsequent
reduction in CRC has been well studied and established in western population. This has led to
formulation of national screening colonoscopy programs elsewhere. However, data from Indian
subcontinent is scanty. In current study, at a large tertiary care center, we aimed to study
prevalence of colonic polyps and adenoma who are undergoing diagnostic colonoscopy using high
definition colonoscopy and characterizing with Narrow Band Imaging and to find associated
demographic, social, personal and family related risk factors in patients with adenomas.
Methodology:
This will be a prospective, single center, observational study. All subjects referred for
diagnostic colonoscopy will be prospectively enrolled.
Enrollment:
All subjects referred for the diagnostic colonoscopy will be enrolled. A member of the
research team will approach each subject to discuss participation in the study, including
background of the proposed study, inclusion and exclusion criteria, benefits and risks of the
procedures and follow-up. If this is of interest to the subject, the informed consent form is
discussed and presented. The subject must sign the consent form prior to enrollment. This
form will have prior approval of the study site's Institutional Review Board (IRB). Failure
to obtain informed consent renders the subject ineligible for the study.
Study equipment
Colonoscope:
Olympus HDWL colonoscope will be used to perform colonoscopies. Technical specifications
include outer diameter 13.2 mm, instrument channel diameter 3.7 mm, air-water suction
channels, field of view 170 degrees, 4-way angulations (180 degrees up and 180 degrees down,
160 degrees right and left), working length, 168 cm.
Colonoscopy procedure and definitions
For all patients, either moderate sedation with intravenous midazolam or conscious sedation
with intravenous propofol will be administered in a standard fashion prior to undergoing
colonoscopy.
The colonoscope will be inserted and cecum will be intubated. Photo documentation of the
cecum will be performed. The colonic mucosa will be carefully visualized upon withdrawal of
the colonoscope.
The time from the point of insertion of the colonoscope into the rectum to the intubation of
cecum will be recorded with a stop watch by a research coordinator and will be documented as
the "insertion time".
The time spent in inspecting the mucosa during withdrawal of the colonoscope will be
documented as the "withdrawal time". During withdrawal of the colonoscope the stop watch will
be stopped whenever mucosa is being cleaned, fluid/solid debris is suctioned or a polyp is
being removed to ensure that the withdrawal time is the actual representation of the mucosal
inspection time. Meticulous technique will be employed during the withdrawal phase with
special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral
folds, flexures and valves.
All polyps detected will be documented: size, location, and morphology (using the Paris
classification - Appendix A and Narrow Band Imaging classification - NICE and JNET). Photo
documentation of the polyps will be performed.
Polyps will then be removed with a biopsy forceps or snare and sent for histopathological
evaluation, each in a separate jar and labeled accordingly.
The bowel preparation will be evaluated and graded according to previously reported criteria
using the Boston Bowel Preparation Scale. Complications including post colonoscopy pain,
perforation or gastrointestinal bleeding (requiring intervention) will be recorded.
Adverse events:
The primary investigator at each site will monitor any adverse events reported to the study
staff and determine if it's related to the study procedures including standard colonoscopy at
the respective site. All adverse events will be monitored until a satisfactory resolution and
will be reported to the local IRB within 5 days of knowledge. A table will be maintained for
the adverse events in each arm and in case of any statistically significant adverse even rate
in any arm, the primary investigator will make the decision to remove the treatment arm or
stop the study. Because the risks of this proposed study are low, this program will not
require a Data Safety and Monitoring Board. Instead, the Principal Investigator and clinical
Site Investigators performing the endoscopies will be responsible for implementing a detailed
Data and Safety Monitoring plan in compliance with the IRB guidelines.
Data integrity and safety:
All paper charts pertaining to the patient will be kept under lock and key in coordinators
office away from the endoscopy area. The data will be entered in to a data base weekly after
collection of histology reports. The data is password protected and stored on the AIG
internal server where it will remain throughout the study. Computers and/or files will be
password-protected. Only approved personnel by the IRB will have access to the file storage.
To protect subject confidentiality, each subject will be assigned a case study number. The
subject's name is not to appear anywhere on the Case Report Forms (CRF's) or supporting
documentation. A study log with the identifiable information will be kept in a separate
folder to enable the investigators to assist in any research audit. No procedural data except
the date of examination will be entered in to this log.
