| Literature DB >> 32967616 |
Zhixin Zhang1,2, Yonghong Xia3, Hongyao Cui4, Xin Yuan1,2, Chunnian Wang5, Jiarong Xie1,2, Yarong Tong3, Weihong Wang6, Lei Xu7.
Abstract
BACKGROUND: Underwater endoscopic mucosal resection (UEMR) is a recently developed technique and can be performed during water-aided or ordinary colonoscopy for the treatment of colorectal polyps. The objective of this clinical trial was to evaluate the efficacy and safety of UEMR in comparison with conventional endoscopic mucosal resection (CEMR) of small non-pedunculated colorectal polyps.Entities:
Keywords: Colonic polyps; Colorectal cancer; Conventional endoscopic mucosal resection; Endoscopy; Underwater endoscopic mucosal resection
Mesh:
Year: 2020 PMID: 32967616 PMCID: PMC7510164 DOI: 10.1186/s12876-020-01457-y
Source DB: PubMed Journal: BMC Gastroenterol ISSN: 1471-230X Impact factor: 3.067
Fig. 1Underwater endoscopic mucosal resection (UEMR). a A flat elevated polyp was detected in the colon; b The colorectal lumen was completed deflated with sterile water; c The polypectomy snare was used for UEMR; d Biopsies were obtained from two marginal sites located symmetrically to the left and right of mucosal defects to confirm residual polyp tissue
Baseline characteristics of the study participants
| Parameter | CEMR | UEMR | Total | |
|---|---|---|---|---|
| Age, mean (SD), yrs | 57.6 ± 9.8 | 55.1 ± 11.2 | 56.4 ± 10.6 | 0.177a |
| Sex, | ||||
| Male | 35 (54.7) | 40 (60.6) | 75 (57.7) | 0.495b |
| Female | 29 (45.3) | 26 (39.4) | 55 (42.3) | |
| Current alcohol, | 0.866b | |||
| Yes | 13 (20.3) | 11 (16.7) | 24 (18.5) | |
| No | 39 (60.9) | 42 (65.6) | 81 (62.3) | |
| Unknow | 12 (18.8) | 13 (19.7) | 25 (19.2) | |
| Current tobacco, | 0.910b | |||
| Yes | 11 (17.2) | 13 (19.7) | 24 (18.5) | |
| No | 41 (64.1) | 40 (60.6) | 81 (62.3) | |
| Unknow | 12 (18.8) | 13 (19.7) | 25 (19.2) | |
| Institution, | 0.441b | |||
| A | 51 (79.7) | 51 (77.3) | 102 (78.5) | |
| B | 10 (15.6) | 14 (21.2) | 24 (18.4) | |
| C | 3 (4.7) | 1 (1.5) | 4 (3.1) | |
BMI body mass index, CEMR conventional endoscopic mucosal resection, UEMR, underwater endoscopic mucosal resection. a Two-sample t test. b Chi-square test
Institution A: Ningbo First Hospital, Ningbo, China
Institution B: Ninghai Second Hospital, Ningbo, China
Institution C: Haishu Second Hospital, Ningbo, China
Colorectal polyps in the study participants
| Parameter | CEMR | UEMR | Total | |
|---|---|---|---|---|
| Median Size, (IQR, mm) | 5.0 (4.0–7.0) | 6.0 (5.0–8.0) | 6.0 (4.0–7.0) | 0.061a |
| Location, | 0.612b | |||
| Ascending colon | 16 (22.5) | 13 (18.3) | 28 (20.4) | |
| Transverse colon | 17 (23.9) | 21 (29.6) | 38 (26.8) | |
| Descending colon | 5 (7.1) | 6 (8.4) | 11 (7.7) | |
| Sigmoid colon | 28 (39.4) | 22 (31.0) | 50 (35.2) | |
| Rectum | 5 (7.1) | 9 (12.7) | 14 (9.9) | |
| Morphology, | 0.339b | |||
| 0-Is | 50 (70.4) | 54 (76.1) | 104 (73.2) | |
| 0-Ip | 0 (0.0) | 1 (1.4) | 1 (0.7) | |
| 0-IIa | 21 (29.6) | 16 (22.5) | 37 (26.1) | |
| Neoplastic polyps, | 0.618b | |||
| Tubular | 47 (66.2) | 48 (67.6) | 95 (66.9) | |
| Tubulovillous or villous | 0 (0.0) | 2 (2.8) | 2 (1.4) | |
| SSA | 1 (1.4) | 1 (1.4) | 2 (1.4) | |
| Other polyps, | ||||
| Hyperplastic polyps | 13 (18.3) | 9 (12.7) | 22 (15.5) | |
| Inflammatory polyps | 10 (14.1) | 11 (15.5) | 21 (14.8) |
CEMR conventional endoscopic mucosal resection, UEMR underwater endoscopic mucosal resection, SSA sessile serrated adenoma
a Wilcoxon rank-sum test. b Chi-square test
Fig. 2Schematic diagram of patient enrollment and study design. A total of 130 patients with 142 colorectal polyps were allocated randomly to the CEMR or UEMR group
Comparative analysis of primary outcomes
| Parameter | CEMR | UEMR | |
|---|---|---|---|
| Intention-to-treat analysis | |||
| Complete resection, | 62 | 59 | |
| Rate (%) [90% CI] | 87.3 [80.7–94.0] | 83.1 [75.6–90.6] | 0.478a |
| Incomplete resection, | 9 (12.7) | 12 (16.9) | |
| En-bloc, | 65 | 67 | |
| Rate (%) [90% CI] | 91.5 [86.0–97.1] | 94.4 [89.8–99.0] | 0.512a |
| Piecemeal, | 6 (8.5) | 4 (5.6) | |
| Per-protocol analysis | |||
| Complete resection, | 62 | 59 | |
| Rate (%) [90% CI] | 87.3 [80.7–94.0] | 89.4 [83.0–95.8] | 0.706a |
| Incomplete resection, | 9 (12.7) | 7 (10.6) | |
| En-bloc, | 65 | 62 | |
| Rate (%) [90% CI] | 91.5 [86.0–97.1] | 93.9 [89.0–98.9] | 0.591 a |
| Piecemeal, | 6 (8.5) | 4 (6.1) |
CEMR conventional endoscopic mucosal resection, UEMR underwater endoscopic mucosal resection
aChi-square test
Fig. 3Non-inferiority graph for primary outcomes. Datapoints are the point estimate of the risk difference between the CEMR and UEMR, error bars are 90% CI
Comparative analysis of secondary outcomes
| Parameter | CEMR | UEMR | Total | |
|---|---|---|---|---|
Median procedure time (IQR, second) | 81 (52–113) | 72 (53–83) | 0.183a | |
| Adverse event | ||||
| Bleeding | 1 | 1 | 2 | 1.000b |
| Perforation | 0 | 0 | 0 | / |
| Delayed bleeding | 2 | 0 | 2 | 0.240b |
| Delayed perforation | 0 | 0 | 0 | / |
| Unfollowed | 4 | 3 | 7 | 0.716b |
CEMR conventional endoscopic mucosal resection, UEMR underwater endoscopic mucosal resection
Bleeding defined as prolonged post-polypectomy bleeding (> 30 s)
Delayed bleeding was defined as the presence of bloody stool and endoscopic hemostasis during 7–14 days’ follow-up
aWilcoxon rank-sum test
bTwo-tailed Fisher exact test