UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062206 |
|---|---|
| Receipt number | R000070783 |
| Scientific Title | An Interventional Study to Evaluate the Safety and Efficacy of the Line-anchored Ligation and Cutting (LiLAC) Method for the Pedunculated Colonic Lesion with a Giant Head |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/10 17:40:10 |
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Basic information
Public title
A study of ligation and resection technique for pedunculated colorectal polyps
Acronym
An interventional study of ligation and resection technique
Scientific Title
An Interventional Study to Evaluate the Safety and Efficacy of the Line-anchored Ligation and Cutting (LiLAC) Method for the Pedunculated
Colonic Lesion with a Giant Head
Scientific Title:Acronym
An interventional study of LiLAC method
Region
| Japan |
Condition
Condition
giant pedunculated colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate safety and efficacy of the LiLAC method in pedunculated colorectal lesions where the deployment of a detachable snare is not possible
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post-polypectomy bleeding (PPB) incidence
PPB is defined as bleeding that meets any of the following criteria:
1. Bleeding resulting in a decrease in serum hemoglobin levels of 2 g/dL or more from the pre-procedure value.
2. Bleeding that required endoscopic hemostasis or blood transfusion (regardless of whether it occurred during or after the procedure)
PPB is categorized and tabulated based on timing as follows:
1. Immediate bleeding: occurring during the procedure
2. Delayed bleeding: occurring from the end of the procedure to 30 days later
Key secondary outcomes
En bloc resection rate: The proportion of lesions that were resected as a single continuous specimen
R0 en bloc resection rate: The proportion of en bloc resections in which both horizontal and vertical margins were negative pathologically
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
LiLAC technique applied to pedunculated colorectal polyps unsuitable for conventional detachable snare ligation: a silk suture is fixed to the colonic wall with a clip, looped around the polyp stalk using biopsy forceps, ligated, and the polyp is then resected using a cutting device
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Pedunculated lesions discovered during colonoscopy (Paris classification Ip type)
2. Lesions that the endoscopist judged physically impossible to deploy and place a detachable snare on (no numerical cutoff for head diameter is set)
3. Lesions judged appropriate for endoscopic resection (including intramucosal carcinoma and minimally invasive submucosal carcinoma)
4. Age 20 years or older
5. Patients from whom written consent has been obtained
Key exclusion criteria
1. Coagulation dysfunction (PT-INR >1.5 or platelet count <50,000/mm3)
2. Patients who cannot discontinue antithrombotic agents
3. Acute enteritis or active inflammatory bowel disease
4. Poor general condition (ASA classification IV or higher)
5. Pregnant patients or those who may be pregnant
6. Lesions around the anastomosis
7. Patients with a stem diameter of 4 mm or less, where there is a risk that the stem may be cut during the ligation procedure
8. Patients who underwent electrocautery resection for multiple lesions
9. Patients lacking the ability to give consent
10. Patients deemed inappropriate by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | TAKESHI |
| Middle name | |
| Last name | MINE |
Organization
Naha City Hospital
Division name
Department of gastroenterology
Zip code
902-8511
Address
2-31-1 Furujima, Naha City, Okinawa, Japan
TEL
0988845111
minetgie@gmail.com
Public contact
Name of contact person
| 1st name | TAKESHI |
| Middle name | |
| Last name | MINE |
Organization
Naha City Hospital
Division name
Department of gastroenterology
Zip code
902-8511
Address
2-31-1 Furujima, Naha City, Okinawa, Japan
TEL
0988845111
Homepage URL
minetgie@gmail.com
Sponsor or person
Institute
Naha City Hospital
Institute
Department
Personal name
Takeshi Mine
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee of Naha City Hospital
Address
2-31-1 Furu-jima, Naha City, Okinawa, Japan
Tel
0988845111
chiken@nahacity-hospital.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
那覇市立病院/Naha City Hospital
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2029 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2030 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 10 | Day |
Last modified on
| 2026 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070783
