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Adenomatous Polyp clinical trials

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NCT ID: NCT01675752 Completed - Adenomatous Polyp Clinical Trials

Small Hyperplastic and Adenomatous Reliability Protocol

SHARP
Start date: May 2011
Phase: N/A
Study type: Observational

1. Protocol Summary Title: SHARP: Small Hyperplastic and Adenomatous Reliability Protocol Purpose: To compare the accuracy of NBI-in vivo differentiation between hyperplastic and adenomatous <10 mm polyps with that of histology in an European multi-center study. To assess variability among endoscopists in NBI accuracy. We also aim to assess whether this technology impacts the appropriateness of surveillance intervals. Design: 1) Before starting the patient enrollment, the participating endoscopists will attend an internet-based training program on the in vivo differentiation between hyperplastic and adenomatous polyps. Following this course, a qualifying examination will be required for each endoscopist to be included. 2) Patients who are scheduled for screening or diagnostic colonoscopy will be considered for inclusion. Patients with at least one histologically verified <10 mm polyp will be included. In order to measure NBI feasibility, each included polyp will be in vivo assessed by NBI in order to rank between a high- and a low- level of diagnostic confidence, and thereafter will be sent for histological assessment. NBI- and histological accuracy in differentiating between hyperplastic and adenomatous lesions will be analyzed and compared, in order to assess the NBI-sensitivity and specificity. The primary outcomes are to measure the NBI feasibility and accuracy in the study population, and to assess the variability among the endoscopists. Secondary outcome measures will be a cost analysis on how much savings would be achieved by not referring NBI-diagnosed hyperplastic polyps to histology, and a clinical inference on how many patients would be scheduled for an inappropriate post-polypectomy follow up, when follow up schedule is based on NBI classification. Clinical results will be analyzed using various statistical measures of significance. Clinical Site Locations: 10 European centres with NBI-technology 1 NBI-expert endoscopist for each centre Enrollment: 160 small (<10 mm) polyps at each site Study technology: NBI-Olympus without optical magnification Risk: Non-interventional study.

NCT ID: NCT01656746 Completed - Crohn Disease Clinical Trials

Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

Start date: May 2010
Phase: N/A
Study type: Interventional

This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases

NCT ID: NCT01312467 Completed - Obesity Clinical Trials

Trial of Metformin for Colorectal Cancer Risk Reduction for History of Colorectal Adenomas and Elevated BMI

Start date: March 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out whether METFORMIN decreases protein markers in colorectal tissue. This is a phase IIA study of the pharmacodynamics, safety and tolerability of Metformin in decreasing colorectal mucosa in patients with a history of colorectal adenomas in the past 3 years and a BMI >= 30, with decimals rounded to the nearest whole integer. Metformin as a potential chemopreventive agent for inhibition of the relevant molecular pathways involved in human colorectal carcinogenesis.

NCT ID: NCT01133041 Completed - Colonoscopy Clinical Trials

Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

Start date: May 2010
Phase: Phase 4
Study type: Interventional

Several novel imaging technologies are currently used for detection and differentiation of colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan (Pentax). Several previous studies have indicated that NBI without magnification can be useful for real-time differentiation of diminutive colonic neoplasias. To date, however, there are no studies comparing NBI with other imaging systems (FICE or i-Scan) for differentiation of diminutive colonic polyps. The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in real-time prediction of diminutive colonic polyps. In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will be observed with conventional colonoscopy, thereafter will be observed with new imaging systems. Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by reference to histological results obtained by endoscopic biopsy or polypectomy.

NCT ID: NCT01124266 Completed - Colonoscopy Clinical Trials

Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

Start date: May 2010
Phase: Phase 4
Study type: Interventional

Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy. The aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary outcome measure is the adenoma detection rate (ADR).

NCT ID: NCT00983580 Completed - Adenomatous Polyp Clinical Trials

Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer

Start date: August 20, 2009
Phase: Phase 2
Study type: Interventional

This phase II trial is studying how well giving acetylsalicylic acid together with eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and eflornithine may prevent colorectal cancer.

NCT ID: NCT00828984 Completed - Clinical trials for Colorectal Carcinoma

Macrogol 3350-based Oral Osmotic Laxative in Preventing Cancer in Patients at Risk of Colorectal Cancer

Start date: October 2009
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well macrogol 3350-based oral osmotic laxative (polyethylene glycol 3350) works in preventing cancer in patients at risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of macrogol 3350-based oral osmotic laxative may stop cancer from growing in patients who are at risk of colorectal cancer.

NCT ID: NCT00754494 Completed - Clinical trials for Recurrent Rectal Cancer

Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma

Start date: July 2008
Phase: Phase 2
Study type: Interventional

This randomized phase II trial is studying how well erlotinib hydrochloride works in treating patients with stage I-III colorectal cancer or adenoma. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Erlotinib hydrochloride may also stop tumors from growing or coming back

NCT ID: NCT00614770 Completed - Adenomatous Polyp Clinical Trials

Narrow Band Imaging Colon Polyp Study

Start date: February 2008
Phase: N/A
Study type: Interventional

In this study the investigators hypothesize that High Definition White Light colonoscopy and narrow band imaging (NBI) will detect a higher number of adenomas compared to standard definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp histology compared to high definition colonoscopy and standard colonoscopy. Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy, high-definition white light colonoscopy and NBI. Specific Aim 2 - To compare the number of adenoma detected per subject by standard colonoscopy, high-definition white light colonoscopy and NBI. Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface mucosal and vascular patterns during the procedure. Specific Aim 4 - To determine the inter-observer agreement between investigators for the recognition of various polyp patterns

NCT ID: NCT00613262 Recruiting - Colonoscopy Clinical Trials

A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging

NBI
Start date: April 2012
Phase: N/A
Study type: Interventional

The investigators hypothesize that NBI will have a high accuracy in predicting polyp histology real time during a colonoscopy by visualization of the surface mucosal and vascular patterns. Aim#1: To determine the sensitivity, specificity and accuracy of NBI and standard white light colonoscopy for predicting polyp histology by evaluating the surface mucosal and vascular patterns during colonoscopy. Aim#2: To determine the inter-observer agreement between investigators for the recognition of various polyp patterns.