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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000025754 |
Receipt No. | R000026835 |
Scientific Title | Safety and efficacy of Tip-in endoscopic mucosal resection for large flat colorectal Adenomas: a Randomized control trial |
Date of disclosure of the study information | 2017/02/14 |
Last modified on | 2021/02/02 |
Basic information | ||
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 |
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Condition | ||
Condition | large flat colorectal adenomas | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
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 |
Assessment | |
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 |
Base | |
Study type | Interventional |
Study design | |
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 |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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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 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
k.imai1977@gmail.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
k.imai1977@gmail.com |
Sponsor | |
Institute | Division of Endoscopy, Shizuoka Cancer Center |
Institute | |
Department |
Funding Source | |
Organization | Division of Endoscopy, Shizuoka Cancer Center |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Shizuoka Cancer Center |
Address | 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan |
Tel | 055-989-5222 |
ke.imai@scchr.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |||||||
URL related to results and publications | |||||||
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 |
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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 |
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Recruitment status | No longer recruiting | ||||||
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Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026835 |
Research Plan | |
Registered date | File name |
2020/01/23 | Tipin研究計画書第5版.pdf |
Research case data specifications | |
Registered date | File name |
2020/01/23 | 【先端穿刺法EMR試験】症例登録進捗状況一覧表2019年3月 のコピー.pdf |
Research case data | |
Registered date | File name |
2021/02/02 | STARtrialデータUMIN登録用.xls |