UMIN-CTR Clinical Trial

Public title

Safety and efficacy of Tip-in endoscopic mucosal resection for large flat colorectal Adenomas: a Randomized control trial

Acronym

STAR trial

Scientific Title

Safety and efficacy of Tip-in endoscopic mucosal resection for large flat colorectal Adenomas: a Randomized control trial

Scientific Title:Acronym

STAR trial

Region

Japan

Condition

large flat colorectal adenomas

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the safety and efficacy of the Tip-in EMR technique for large flat colorectal adenomas (15-25 mm in diameter) in randomized comparison with conventional EMR method.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

En bloc resection rate in intention-to-treat analysis

Key secondary outcomes

1.En bloc resection rate in per-protocol analysis
2. Complete R0 resection rate
3. One-year accumulate recurrence rate
4. En bloc resection rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter)
5. One-year accumulate recurrence rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter)
6. Complete R0 resection rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter)
7. En bloc resection rate by lesion location
8. One-year accumulate recurrence rate in en bloc resection group and piecemeal resection group
9. One-year accumulate recurrence rate in R0 resection group and R1resection group
10. One-year accumulate recurrence rate in cases of RX resection
11. Rate of exclusion by poor lesion lifting in cases with previous biopsies
12. Complication rate
13. Accuracy of endoscopic diagnosis for residual adenomas during surveillance tests

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

conventional EMR

Interventions/Control_2

Tip-in EMR technique

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with a large flat adenoma (15-25 mm in size)
2. Patients aged over 20 years old when consents to the participation is obtained
3. Ptients consented after full understanding of this study

Key exclusion criteria

1. Cases with clinical diagnosis of T1 cancer
2. Cases with difficulties to interrupt intake of anticoagulant drugs
3. Inappropriate cases by investigators

Target sample size

80

Name of lead principal investigator

1st name	Kenichiro
Middle name
Last name	Imai

Organization

Shizuoka Cancer Center

Division name

Division of Endoscopy

Zip code

411-8777

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

TEL

055-989-5222

Email

k.imai1977@gmail.com

Name of contact person

1st name	Kenichiro
Middle name
Last name	Imai

Organization

Shizuoka Cancer Center

Division name

Division of Endoscopy

Zip code

411-8777

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

TEL

055-989-5222

Homepage URL

Email

k.imai1977@gmail.com

Institute

Division of Endoscopy, Shizuoka Cancer Center

Institute

Department

Personal name

Organization

Division of Endoscopy, Shizuoka Cancer Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shizuoka Cancer Center

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

Tel

055-989-5222

Email

ke.imai@scchr.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

2017

Year

02

Month

14

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026835

Publication of results

Published

URL related to results and publications

https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000026835

Number of participants that the trial has enrolled

85

Results

We analyzed 41 lesions in the Tipin EMR group and 41 lesions in the EMR group. En bloc resection was achieved in 37 (90.2 percent) patients in the Tipin EMR group and 30 (73.1 percent) in the EMR group. The adjusted odds ratio of en bloc resection in Tip-in EMR vs. EMR was 3.46 (95 percent CI 1.06 to 13.6) with a significant difference (P 0.040). There were no differences between Tipin EMR and EMR in adverse events (0 vs 4.8 percent) and median procedure time (7 vs 5 min).

Results date posted

2021

Year

02

Month

02

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

There were no differences between the two groups in median tumor size, size distribution category, location, morphology, and LST subtype (Table 1). Biopsy had previously been attempted in 5 (12.2%) cases in the CEMR group and in 13 (31.7%) in the Tip-in EMR group. At EMR, lesion lifting after submucosal injection was poor in 7 (17.1%) in the CEMR group and 10 (24.4%) in the Tip-in EMR group.

Participant flow

From February 2017 to August 2018, a total of 234 colorectal lesions were assessed for study eligibility during colonoscopy at our institution and a total of 85 lesions were enrolled (Figure 2). With regards to group allocation, 42 lesions were assigned to the CEMR group and 43 to the Tip-in EMR group. After randomization, EMR was not carried out due to patient consent withdrawal in one case in each group because the patients and their families had hoped to receive the ESD treatment to assure complete resection and were hesitant to receive the frequent surveillance colonoscopies in the study protocol. Another lesion was strongly suspected to be deeply invasive submucosal cancer just prior to Tip-in EMR and transferred to ESD. The ESD specimen revealed deep invasive cancer, thus this patient was referred for additional surgery. Finally, 41 lesions (25 in the 15 to 20 mm and 16 in the 21 to 25 mm size category) in the CEMR group and 41 lesions (24 in the 15 to 20 mm and 17 in the 21 to 25 mm size category) in the Tip-in EMR group were included in the analysis.

Adverse events

There was no evidence of differences in adverse-event rates including bleeding and perforation between CEMR and Tip-in EMR (Table 5). After EMR, snare-tip coagulation was performed as hemostasis for intraprocedural oozing in 1 CEMR patient. Emergent endoscopy was done for 1 case with hematochezia 2 days after CEMR. Bleeding stopped spontaneously and prophylactic clip closure of the defect was completed.

Outcome measures

In the intention to treat analysis, en bloc resection was achieved in 30 (73.1 percent) lesions in the CEMR group and 37 (90.2 percent) in the Tip-in EMR group. The adjusted odds ratio of en bloc resection of Tip-in EMR vs CEMR was 3.46 (95 percent confidence interval 1.06 to 13.6) with a significant difference (P = 0.040; Table 2). After initial snaring, residual neoplasms were identified in 11 (26.9 percent) patients in the CEMR group and in 4 (9.8%) in the Tip-in EMR group. Additional snare resection was done with a median of 2 snare resections in 9 (22.0 percent) lesions in the CEMR group and 4 (9.8 percent) in the Tip-in EMR group. Cold biopsies were added to the initial resection in 2 (4.9 percent) lesions in the CEMR group. Median procedure time was similar between the two groups (5 vs 7 min, Table 3). The completion of resection was confirmed by NBIME in all cases. Recurrence at 6-month SC in 15 CEMR and in 8 Tipin EMR lesions was detected in 1 of each group after piecemeal resection. Residual tumors were removed by cold forceps polypectomy. Recurrence at 12-month SC in 38 CEMR and 35 Tipin EMR lesions was detected in 2 of the CEMR group. One was detected and removed at the 6-month SC and another was initially detected at the 12-months SC after en bloc resection with pathologically negative margins. Each residual adenoma was removed by EMR and diagnosed as low-grade tubular adenoma. The final cumulative recurrent rates were 5.2 percent (2/38) and 2.8 percent (1/35) in the CEMR and Tipin EMR group, respectively. Resection completion was predicted by NBIME in 95.9 percent (70/73, 95percent CI: 88.5 to 99.1 percent).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

01

Month

17

Day

Date of IRB

2017

Year

01

Month

17

Day

Anticipated trial start date

2017

Year

01

Month

29

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

01

Month

20

Day

Last modified on

2025

Year

02

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026835

Single case data URL

Value
https://center6.umin.ac.jp/ice/26835