UMIN-CTR Clinical Trial

Public title

Randomized controlled trial of post-resecting hemorrhage suppression effect of adrenergic saline submucosal injection in cold snare polypectomy for colorectal adenomatous polyps less than 10 mm

Acronym

Randomized controlled trial of post-resecting hemorrhage suppression effect of adrenergic saline submucosal injection in cold snare polypectomy for colorectal adenomatous polyps less than 10 mm

Scientific Title

Randomized controlled trial of post-resecting hemorrhage suppression effect of adrenergic saline submucosal injection in cold snare polypectomy for colorectal adenomatous polyps less than 10 mm

Scientific Title:Acronym

Randomized controlled trial of post-resecting hemorrhage suppression effect of adrenergic saline submucosal injection in cold snare polypectomy for colorectal adenomatous polyps less than 10 mm

Region

Japan

Condition

adenomatous polyp and serrated lesion in colorectum less than 10mm

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Adenomatous polyps and serrated lesions smaller than 10 mm are treated with the conventional cold snare polypectomy and cold snare polypectomy with the submucosal injection of 0.001% adrenalin-supplemented saline. The time required for endoscopic resection is examined in a randomized controlled trial.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Required time for cold snare polypectomy (time from start of resection to confirmation of natural hemostasis and no residual lesion)

Key secondary outcomes

Total colon observation and total treatment time, all adverse events that occurred during endoscopic observation and treatment. Bleeding rate after polypectomy. Amount of change in vital signs such as blood pressure and pulse before and after treatment.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Submucosal injection of 0.001% adrenalin-added saline before cold snare polypectomy for adenomas and serrated tumors smaller than 10 mm.

Interventions/Control_2

Conventional cold snare polypectomy

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Patients with colorectal adenomas and serrated tumors smaller than 10mm.
2) Patients who are 20 to 80 years old at the time of obtaining informed consent.
3) Patients for whom informed consent was obtained in this study.

Key exclusion criteria

Patients with above;
1) Incomplete cecal insertion
2) extreme poor bowel preparation
3) Inflammatory bowel disease
4) Active digestive tract bleeding
5) Intestinal stenosis
6) Toxic megacolon
7) Active diverticulitis
8) Familial polyposis coli and Lynch syndrome
9) Not stopping with antithrombotic drugs before examination
10) Unable to rest for a week after colonoscopic procedure
11) Not wishing resection for detected lesions
12) suffering from serious physical and mental illness
13) Judged to be ineligible by the investigator

Target sample size

128

Name of lead principal investigator

1st name	Atsushi
Middle name
Last name	Katagiri

Organization

Showa University Hospital

Division name

Department of Medicine, Division of Gastroenterology

Zip code

142-8666

Address

1-5-8 Hatanodai,Shinagawa-ku,Tokyo

TEL

0337848535

Email

katsushi@med.showa-u.ac.jp

Name of contact person

1st name	Atsushi
Middle name
Last name	Katagiri

Organization

Showa University Hospital

Division name

Department of Medicine, Division of Gastroenterology

Zip code

142-8666

Address

1-5-8 Hatanodai,Shinagawa-ku,Tokyo

TEL

0337848535

Homepage URL

Email

katsushi@med.showa-u.ac.jp

Institute

Showa University

Institute

Department

Personal name

Organization

Showa University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Showa University

Address

1-5-8 Hatanodai,Shinagawa-ku,Tokyo

Tel

03-3784-8129

Email

m-rinri@ofc.showa-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

02

Month

01

Day

URL releasing protocol

https://www.cureus.com/articles/146214-submucosal-injection-using-epinephrine-added-saline-in-cold-s

Publication of results

Unpublished

URL related to results and publications

https://www.cureus.com/articles/146214-submucosal-injection-using-epinephrine-added-saline-in-cold-s

Number of participants that the trial has enrolled

126

Results

The time required for resection calculated using the least-square mean was significantly shorter in the CEMR group (106.3 s, 95% CI 97.5 to 115.4 s) than in the CSP group (130.9 s, 95% CI 121.2 to 140.7 s) (P < 0.001). The time to spontaneous cessation of immediate bleeding was also significantly shorter in the CEMR group (20.4 s, 95% CI 14.3 to 26.5 s) than in the CSP group (74.2 s, 95% CI 67.6 to 80.7 s) (P < 0.001). Neither group had cases requiring hemostasis, perforation, or delayed bleeding.

Results date posted

2024

Year

07

Month

31

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The mean ( standard deviation; SD) age of the patients in the study was 65.8 ( 12.0) years. Most colonoscopies were performed for surveillance post-polypectomy (54.2%) or positive fecal blood tests (20.3%). Moreover, 20 (16.9%) patients were on anticoagulant drugs (terminated for an appropriate period before the colonoscopy in compliance with guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment: 2017 Appendix on Anticoagulants Including Direct Oral Anticoagulants [19]). The proportion of patients who underwent colonoscopy under the use of midazolam, pethidine hydrochloride, or both was 91.5% of the total cohort: 94.9% in the CEMR group, and 88.1% in the CSP group. The proportions of patients with excellent bowel cleansing were 76.3%, 71.2%, and 81.4% in the total cohort, CEMR group, and CSP group, respectively. The mean ( SD) cecal intubation time was 5.8 ( 3.1) min, 6.2 ( 3.5) min in the CEMR group, and 5.5 ( 2.6) min in the CSP group. The mean ( SD) withdrawal time was 11.9 ( 3.1) min in the total cohort, 12.6 ( 3.1) min in the CEMR group, and 11.2 ( 2.9) min in the CSP group. The mean ( SD) number of resected valid polyps per patient was 2.6 1.9 in the CEMR group and 1.9 1.3 in the CSP group.

Participant flow

etween June 2019 and April 2021, 151 patients were recruited, and 148 patients were enrolled in the study. Twenty-one patients without polyps or with lesions but no target lesions and one who did not undergo total colonoscopy were excluded from the analysis. Thus, a total of 126 patients were randomized; 63 patients were allocated to the CEMR group, and 63 patients to the CSP group. Four patients in the CEMR group and four in the CSP group were excluded because they were identified to be ineligible after treatment allocation. One patient in the CEMR group was randomized, even though insertion to the cecum was not performed. Three patients in the CEMR group and four patients in the CSP group were more than 80 years of age. In the remaining 118 patients, a total of 261 targeted lesions resected using CSP (149 lesions in 59 patients in the CEMR group and 112 lesions in 59 patients in the CSP group) were finally analyzed.

Adverse events

No lesions required hemostasis for CSP-IB. Nausea after colonoscopy occurred in two (3.4%) patients in the CEMR group. Submucosal hematoma occurred immediately after the procedure in one (0.9%) lesion in the CSP group, and preventive hemostasis with an endoscopic clip was performed. No cases of perforation or delayed bleeding occurred in either group.

Outcome measures

The time required for resection calculated as the least square mean was significantly shorter in the CEMR group than in the CSP group, and the difference between the two groups was -24.6 s (95% CI -37.9 to -11.4 s). The time required to cessation of immediate bleeding was also significantly shorter in the CEMR group than in the CSP group, and the differences were -53.7 s (95% CI -62.7 to -44.8 s).

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2019

Year

03

Month

11

Day

Date of IRB

2019

Year

03

Month

11

Day

Anticipated trial start date

2019

Year

06

Month

24

Day

Last follow-up date

2021

Year

04

Month

16

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

01

Month

28

Day

Last modified on

2024

Year

07

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041575