Background
Methods
Assignment to interventions
Outcome measures
Baseline Characteristics
Primary outcome measure
Secondary outcome measure
Sample size determination
Data management and analysis
Systematic review of the current evidence
Results
Randomized Controlled Trial
Parameter | NBI group (n = 241) | Conventional group (n = 241) | Significance (p) |
---|---|---|---|
Age (years) | 57.36 (SD 12.07) | 59.29 (SD 12.91) | Ns |
Gender M/F | 86/155 | 95/146 | Ns |
Weight (kg) | 66.73 (SD 12.99) | 66.43 (SD 12.45) | Ns |
Height (cm) | 163.49 (SD 11.37) | 163.11 (SD 8.57) | Ns |
Total examination time (min)* | 9.21 (SD 3.08) | 9.22 (SD 3.58) | Ns |
Previous colonoscopy | 94 (39.0%) | 98 (40.7%) | Ns |
Indication: | |||
Screening | 42 (17.4%) | 37 (15.4%) | Ns |
Surveillance | 22 (9.1%) | 18 (7.4%) | Ns |
Diagnostic | 177 (73.5%) | 186 (77.2%) | Ns |
Last colonoscopy (years) | |||
1 to 3 | 50 | 51 | Ns |
3 to 5 | 25 | 26 | Ns |
5 to 10 | 11 | 11 | Ns |
> 10 | 8 | 10 | Ns |
Previous polyp resection | 26 (10.8%) | 19 (7.9%) | Ns |
Familial history of colorectal cancer | 44 (18.3%) | 36 (14.9%) | Ns |
Excellent/good bowel preparation | 167 (69.3%) | 162 (67.5%) | Ns |
Outcome | NBI group (n = 241) | Conventional group (n = 241) | Measurement of the intervention effect* | Significance (p) |
---|---|---|---|---|
Total number of polyps (visual inspections) | 77 | 102 | RR 0.75 (0.60 to 0.96) | 0.02 |
Proportion of patients with at least one polyp | 50 (20.8%) | 60 (24.9%) | RR 0.83 (0.60 to 1.16) | Ns |
Mean number of polyps | 0.32 (SD 0.73) | 0.42 (SD 0.93) | MD -0.1 (-0.25 to 0.05) | Ns |
Rate of polyp ≤ 5 mm | 51 (21.2%) | 62 (25.7%) | RR 0.82 (0.59 to 1.14) | Ns |
Mean time to find the first polyp (seconds) | 230.8 (SD 227.20) | 220.81 (SD 233.93) | MD 10.80 (-30.27 to 51.87) | Ns |
Outcomes (Number of polyps by histological category) | NBI group (n = 241) | Conventional group (n = 241) | Measurement of the intervention effect* | Significance (p) |
---|---|---|---|---|
Tubular adenoma or adenomatous polyp | 46 | 47 | 0.98 (0.68 to 1.41) | Ns |
Hyperplastic polyps | 22 | 42 | 0.52 (0.32 to 0.85) | 0.009 |
Villous adenoma | 1 | 1 | 1.00 (0.06 to 15.90) | Ns |
Tubulovillous adenoma | 1 | 9 | 0.11 (0.01 to 0.87) | 0.04 |
Adenocarcinoma | 1 | 1 | 1.00 (0.06 to 15.90) | Ns |
Other type of lesions | 2 | 1 | 2 (0.18 to 21.91) | Ns |
Total number of polyps | 70 | 99 | 0.71 (0.55 to 0.91) | 0.006 |
Total number of lesions | 73 | 101 | 0.71 (0.57 to 0.92) | 0.009 |
Systematic Review of the current evidence
Study | Methods | Participants | Interventions | Primary Outcomes | Risk of bias* |
---|---|---|---|---|---|
Adler 2009 | Open-label, prospective, randomized, controlled, multicenter trial | 1256 patients, mean age, 64.4 years (range 31-87 y) undergoing screening colonoscopy | Wideangle colonoscopy using either conventional high-resolution imaging or NBI during instrument withdrawal (6 endoscopists). Exera II system. | Number of adenomas/number of patients examined | Unclear |
Adler 2008 | Open-label, prospective, randomized, controlled trial | 401 patients with a mean age of 59.4 years (SD 13.4) undergoing diagnostic colonoscopy | Wideangle colonoscopy using either conventional high-resolution imaging or NBI during instrument withdrawal (7 endoscopists). Exera II system. | Adenoma detection rate | Unclear |
East 2009 (abstract) | Open-label, prospective, randomized, controlled trial | 214 high risk adenomas patients with a median age of 65 and 66 years in the NBI and conventional group respectively | Examination with NBI or white light (WLE), with high definition (HDTV) colonoscopes (3 endoscopists). Lucera system. | The number of patients with at least one adenoma detected. | Unclear |
Inoue 2008 | Open-label, prospective, randomized, controlled trial | 243 patients (NBI mean age, 61.1 SD 13.5; conventional mean age 62.9 SD 11.3) undergoing surveillance or diagnostic colonoscopy | Colonoscopy using either conventional high-resolution imaging or NBI during instrument withdrawal (6 endoscopists). Lucera system. | Mean number of adenomas per patient | Unclear |
Kaltenbach 2008 | Open-label, prospective, randomized, controlled trial | 276 patients with a mean age of 64 (SD 10) years (range 31 to 89), undergoing screening, surveillance or diagnostic colonoscopy | Wideangle colonoscopy using either conventional high-resolution imaging or NBI (6 endoscopists); back-to-back colonoscopy by the same endoscopist. Exera II system. | Neoplasm miss rate. | Low |
Paggi 2009 | Open-label, prospective, randomized, controlled trial | 211 patients (from 50 to 69 years) with positive immunologic fecal occult blood tests | Colonoscopy withdrawal in white light versus NBI (6 endoscopists). Exera II system. | The detection rate of adenoma | Unclear |
Rex 2007 | Open-label, prospective, randomized, controlled trial | 434 patients aged 50 years or older undergoing screening or surveillance colonoscopy | Colonoscopy withdrawal in white light versus NBI (only one endoscopist; high definition monitors were used). Exera II system. | Number of adenomas | Unclear |
Sabbagh 2011 | Open-label, prospective, randomized, controlled, multicenter trial | 482 patients with a mean age of 58.3 (SD 12.9) undergoing screening, surveillance or diagnostic colonoscopy | Wideangle colonoscopy using either conventional high-resolution imaging or NBI (3 endoscopists). Exera II system. | Mean number of adenomas |
Study (Year) | Outcome | Conventional colonoscopy (N) | NBI system (N) | RR* WMD** (95%CI) | Heterogeneity (I2) § |
---|---|---|---|---|---|
Adler 2009 East 2009 Inoue 2008 Kaltenbach 2008 Sabbagh 2011 | Mean number of polyps | 1241 | 1238 | WMD -0.07 (-0.21 to 0.07) | 68% |
Adler 2009 Adler 2008 East 2009 Inoue 2008 Kaltenbach 2008 Paggi 2009 Rex 2007 Sabbagh 2011 | Mean number of adenomas | 1768 | 1749 | WMD -0.08 (-0.17 to 0.01) | 62% |
Adler 2009 Adler 2008 Inoue 2008 Kaltenbach 2008 Sabbagh 2011 | Rate of patients with al least one polyp | 1336 | 1330 | RR 0.90 (0.73 to1.11) | 70% |
Adler 2009 Adler 2008 East 2009 Inoue 2008 Kaltenbach 2008 Paggi 2009 Rex 2007 Sabbagh 2011 | Rate of patients with at least one adenoma | 1763 | 1749 | RR 0.96 (0,88 to 1.04) | 0% |
Adler 2009 Adler 2008 Paggi 2009 Sabbagh 2011 | Rate of patients with carcinoma | 1181 | 1169 | RR 1.20 (0.58 to 2.47) | 0% |