Sessile Serrated LesionACID-SSLNCT07601217
Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions
A study testing Acetic Acid-Indigo Carmine Chromocolonoscopy Group in people with Sessile Serrated Lesion, run by Changhai Hospital at 1 site in China.
Trial summary
Chromocolonoscopy with acetic acid and indigo carmine has shown promise for improving the detection of sessile serrated lesions (SSLs), the precursor lesions responsible for a substantial proportion of interval colorectal cancers. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Sessile Serrated Lesion
- What is being tested?
- Acetic Acid-Indigo Carmine Chromocolonoscopy Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,689 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 15 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose age are between 45-85
- Patients who have indications for screening
- Patients who have signed inform consent form.
Who cannot join
- Patients undergoing surveillance colonoscopy after polypectomy or therapeutic colonoscopy for known polyps
- Patients with a history of colonoscopy within the past 5 years
- Patients with highly suspected or confirmed colorectal cancer
- Patients with alarming signs or symptoms: hematochezia, melena, unexplained anemia, weight loss, abdominal mass, positive digital rectal examination
- Pregnant or breastfeeding women
- Patients with gastrointestinal obstruction
Show all 14Show fewer
- Patients with inflammatory bowel disease, colonic polyposis, or melanosis coli
- Patients with coagulation disorders or who have taken antiplatelets or anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy
- Patients currently participating in another clinical trial or who have participated in another clinical trial within the preceding 60 days
- Patients with failed cecal intubation for any reason (e.g., obstructing lesion, intolerance of the procedure)
- Patients with an Aronchick bowel preparation score >3 at colonoscope insertion, indicating inadequate preparation requiring a repeat bowel preparation
- Patients who have used bowel preparation agents not recommended by guidelines, such as oral sodium phosphate or senna
- Patients with known allergy to acetic acid-indigo carmine, brilliant blue dye, or medications related to colonoscopy
- Patients with missing essential information in the case report form prior to enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China, Shanghai Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200433
Zhaoshen Li, MD, 86-021-31161365, li.zhaoshen@hotmail.com
Yu Bai, MD, 86-021-31161335, baiyu1998@hotmail.com
About this study
Official title: Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions: a Multicenter Randomized Trial
Chromocolonoscopy with acetic acid and indigo carmine has shown promise for improving the detection of sessile serrated lesions (SSLs), the precursor lesions responsible for a substantial proportion of interval colorectal cancers. Previous studies have demonstrated its potential to enhance visualization of both adenomatous and non-adenomatous polyps, particularly the subtle SSLs that are frequently missed during conventional white-light colonoscopy. However, high-quality randomized controlled trials comparing chromocolonoscopy with standard white-light imaging to provide definitive evidence on its efficacy for SSL detection are lacking. We therefore conducted a multicenter, prospective, randomized controlled trial to evaluate the diagnostic yield of acetic acid-indigo carmine chromocolonoscopy versus standard colonoscopy for SSL detection.
- Conditions
- Sessile Serrated Lesion
- Being tested
- Acetic Acid-Indigo Carmine Chromocolonoscopy Group, Brilliant Blue Chromocolonoscopy Sham-Control Group
- Keywords
- Sessile Serrated Lesion, Sessile Serrated Lesion Detection Rate, Chromocolonoscopy, Acetic Acid and Indigo Carmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetic Acid-Indigo Carmine Chromocolonoscopy GroupProcedure or surgery
Participants undergo colonoscopy with acetic acid-indigo carmine chromoendoscopy. After successful cecal intubation and randomization, the colonoscope is withdrawn and a spray catheter is used to apply an opaque acetic acid-indigo carmine solution from the cecum to the splenic flexure.
Brilliant Blue Chromocolonoscopy Sham-Control GroupProcedure or surgery
Participants undergo colonoscopy with brilliant blue dye application as a sham chromoendoscopy control to maintain participant blinding. After cecal intubation and randomization, an opaque brilliant blue solution is sprayed from the cecum to the splenic flexure using a spray catheter, with suctioning of any excess dye.
| Study group | Role | What they receive |
|---|---|---|
| Acetic Acid-Indigo Carmine Chromocolonoscopy Group | Experimental | Not described Receives: Procedure: Acetic Acid-Indigo Carmine Chromocolonoscopy Group |
| Brilliant Blue Chromocolonoscopy Sham-Control Group | Sham comparator | Not described Receives: Procedure: Brilliant Blue Chromocolonoscopy Sham-Control Group |
| Conventional White-Light Colonoscopy Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal SSL Detection Rate
The proportion of participants with at least one histologically confirmed sessile serrated lesion detected in the proximal colon (cecum, ascending colon, hepatic flexure, transverse colon, and splenic flexure) during withdrawal examination.
Measured: 60 minutes
Secondary outcomes (2)
Colorectal precancerous lesions detection rate
The proportion of participants with at least one histologically confirmed precancerous lesion (adenoma, or SSL) detected during withdrawal examination.
Measured: 60 minutes
Adenoma Detection Rate
The proportion of participants with at least one histologically confirmed adenoma (tubular, villous, or tubulovillous) detected during withdrawal examination, compared across all three study groups.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Nov 2028 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sessile Serrated LesionStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,689 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Heilongjiang Provicial Hospital, Ankang Central Hospital, Huadong Hospital Affiliated with Fudan University, Shanghai, The First Affiliated Hospital of Nanchang University, Yan'an People's Hospital, The Second Hospital of Hebei Medical University, Chongqing General Hospital, Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital), Shanxi Provincial People's Hospital, Shanghai Sixth Hospital, People's Hospital of Leshan, Sichuan Province, The Third People's Hospital of Chengdu, The Third People's Hospital of Jingdezhen, Ningbo Hospital of Integrated Traditional Chinese and Western Medicine, Shandong Provincial Hospital
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601217
- Sponsor's protocol ID
- CHSSLDR202602
- Acronym
- ACID-SSL
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Crockett SD, Nagtegaal ID. Terminology, Molecular Features, Epidemiology, and Management of Serrated Colorectal Neoplasia. Gastroenterology. 2019 Oct;157(4):949-966.e4. doi: 10.1053/j.gastro.2019.06.041. Epub 2019 Jul 16.
PubMed 31323292Kinugasa H, Hiraoka S, Kobayashi S, Matsubara M, Nagahara T, Higashi R, Takei K, Ohmori M, Nakamura T, Tsuzuki T, Tanaka S, Hirai R, Toyosawa J, Aoyama Y, Yamasaki Y, Inokuchi T, Takahara M, Tanaka T, Mitsuhashi T, Otsuka M; cAIM Study Group. Acetic Acid-Indigo Carmine Chromocolonoscopy for Proximal Serrated Lesions: A Randomized, 3-Arm Colonoscopy Study. Am J Gastroenterol. 2025 Dec 1;120(12):2877-2888. doi: 10.14309/ajg.0000000000003411. Epub 2025 Mar 13.
PubMed 40079452Sung JJY, Chiu HM, Lieberman D, Kuipers EJ, Rutter MD, Macrae F, Yeoh KG, Ang TL, Chong VH, John S, Li J, Wu K, Ng SSM, Makharia GK, Abdullah M, Kobayashi N, Sekiguchi M, Byeon JS, Kim HS, Parry S, Cabral-Prodigalidad PAI, Wu DC, Khomvilai S, Lui RN, Wong S, Lin YM, Dekker E. Third Asia-Pacific consensus recommendations on colorectal cancer screening and postpolypectomy surveillance. Gut. 2022 Nov;71(11):2152-2166. doi: 10.1136/gutjnl-2022-327377. Epub 2022 Aug 24.
PubMed 36002247
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions: a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT07601217
- Acronym / sponsor ID
- ACID-SSL / CHSSLDR202602
- Conditions
- Sessile Serrated Lesion
- Keywords
- Sessile Serrated Lesion, Sessile Serrated Lesion Detection Rate, Chromocolonoscopy, Acetic Acid and Indigo Carmine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,689 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Heilongjiang Provicial Hospital, Ankang Central Hospital, Huadong Hospital Affiliated with Fudan University, Shanghai, The First Affiliated Hospital of Nanchang University, Yan'an People's Hospital, The Second Hospital of Hebei Medical University, Chongqing General Hospital, Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital), Shanxi Provincial People's Hospital, Shanghai Sixth Hospital, People's Hospital of Leshan, Sichuan Province, The Third People's Hospital of Chengdu, The Third People's Hospital of Jingdezhen, Ningbo Hospital of Integrated Traditional Chinese and Western Medicine, Shandong Provincial Hospital
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Nov 2028 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chromocolonoscopy with acetic acid and indigo carmine has shown promise for improving the detection of sessile serrated lesions (SSLs), the precursor lesions responsible for a substantial proportion of interval colorectal cancers. Previous studies have demonstrated its potential to enhance visualization of both adenomatous and non-adenomatous polyps, particularly the subtle SSLs that are frequently missed during conventional white-light colonoscopy. However, high-quality randomized controlled trials comparing chromocolonoscopy with standard white-light imaging to provide definitive evidence on its efficacy for SSL detection are lacking. We therefore conducted a multicenter, prospective, randomized controlled trial to evaluate the diagnostic yield of acetic acid-indigo carmine chromocolonoscopy versus standard colonoscopy for SSL detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acetic Acid-Indigo Carmine Chromocolonoscopy Group | Experimental | Procedure: Acetic Acid-Indigo Carmine Chromocolonoscopy Group |
| Brilliant Blue Chromocolonoscopy Sham-Control Group | Sham comparator | Procedure: Brilliant Blue Chromocolonoscopy Sham-Control Group |
| Conventional White-Light Colonoscopy Group | No intervention | – |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose age are between 45-85
- Patients who have indications for screening
- Patients who have signed inform consent form.
Key exclusion criteria (14 listed)
- Patients undergoing surveillance colonoscopy after polypectomy or therapeutic colonoscopy for known polyps
- Patients with a history of colonoscopy within the past 5 years
- Patients with highly suspected or confirmed colorectal cancer
- Patients with alarming signs or symptoms: hematochezia, melena, unexplained anemia, weight loss, abdominal mass, positive digital rectal examination
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetic Acid-Indigo Carmine Chromocolonoscopy GroupParticipants undergo colonoscopy with acetic acid-indigo carmine chromoendoscopy. After successful cecal intubation and randomization, the colonoscope is withdrawn and a spray catheter is used to apply an opaque acetic acid-indigo carmine solution from the cecum to the splenic flexure. | Procedure or surgery | Acetic Acid-Indigo Carmine Chromocolonoscopy Group |
| Brilliant Blue Chromocolonoscopy Sham-Control GroupParticipants undergo colonoscopy with brilliant blue dye application as a sham chromoendoscopy control to maintain participant blinding. After cecal intubation and randomization, an opaque brilliant blue solution is sprayed from the cecum to the splenic flexure using a spray catheter, with suctioning of any excess dye. | Procedure or surgery | Brilliant Blue Chromocolonoscopy Sham-Control Group |
Primary outcome
Proximal SSL Detection Rate
Time frame: 60 minutes
The proportion of participants with at least one histologically confirmed sessile serrated lesion detected in the proximal colon (cecum, ascending colon, hepatic flexure, transverse colon, and splenic flexure) during withdrawal examination.
2 secondary outcomes
Colorectal precancerous lesions detection rate
Time frame: 60 minutes
Adenoma Detection Rate
Time frame: 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Results publication: PubMed 31323292Crockett SD, Nagtegaal ID. Terminology, Molecular Features, Epidemiology, and Management of Serrated Colorectal Neoplasia. Gastroenterology. 2019 Oct;157(4):949-966.e4. doi: 10.1053/j.gastro.2019.06.041. Epub 2019 Jul 16.
- Results publication: PubMed 40079452Kinugasa H, Hiraoka S, Kobayashi S, Matsubara M, Nagahara T, Higashi R, Takei K, Ohmori M, Nakamura T, Tsuzuki T, Tanaka S, Hirai R, Toyosawa J, Aoyama Y, Yamasaki Y, Inokuchi T, Takahara M, Tanaka T, Mitsuhashi T, Otsuka M; cAIM Study Group. Acetic Acid-Indigo Carmine Chromocolonoscopy for Proximal Serrated Lesions: A Randomized, 3-Arm Colonoscopy Study. Am J Gastroenterol. 2025 Dec 1;120(12):2877-2888. doi: 10.14309/ajg.0000000000003411. Epub 2025 Mar 13.
- Results publication: PubMed 36002247Sung JJY, Chiu HM, Lieberman D, Kuipers EJ, Rutter MD, Macrae F, Yeoh KG, Ang TL, Chong VH, John S, Li J, Wu K, Ng SSM, Makharia GK, Abdullah M, Kobayashi N, Sekiguchi M, Byeon JS, Kim HS, Parry S, Cabral-Prodigalidad PAI, Wu DC, Khomvilai S, Lui RN, Wong S, Lin YM, Dekker E. Third Asia-Pacific consensus recommendations on colorectal cancer screening and postpolypectomy surveillance. Gut. 2022 Nov;71(11):2152-2166. doi: 10.1136/gutjnl-2022-327377. Epub 2022 Aug 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhaoshen Li, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetic Acid-Indigo Carmine Chromocolonoscopy Group in people with Sessile Serrated Lesion, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaoshen Li, MD (86-021-31161365, li.zhaoshen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal SSL Detection Rate (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07601217, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.