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Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

RecruitingNA

Sponsor: Xijing Hospital of Digestive Diseases

Conditions: Colorectal Adenoma, Colorectal Polyps

Interventions: Colonoscopy after bowel cleansing with 2D imaging device, Colonoscopy after bowel cleansing with 3D imaging device

Countries: China

The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to identify patients with high risk adenomas during colonoscopy to guide proper follow-up strategy. It will also learn about the safety of 3-dimensional (3D) imaging device. The main questions it aims to answer are: Does 3-dimensional (3D) imaging device improve the identification of patients with high risk adenomas? What adverse events do participants experience during colonoscopy? Researchers will compare 3-dimensional (3D) imaging device to traditional 2-dimensional (2D) imaging device to see if 3-dimensional (3D) imaging device works to improve high risk adenoma identification. Participants will: Undertake colonoscopy examination using 3-dimensional (3D) imaging device or 2-dimensional (2D) imaging device. Be followed-up to 30 days to record potential colonoscopy-relevant adverse events.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Aged 18-75 years;
* Patients with indications for colonoscopy and receiving diagnostic colonoscopy, without history of inflammatory bowel disease, colorectal cancer, polypectomy or polyposis syndromes;
* Signing the written informed consent;

Exclusion Criteria:

* Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis \[FAP\], Lynch syndrome, etc.);
* Patients with a history of colorectal polypectomy and pathological diagnosed as adenoma;
* Patients with a history of colorectal adenocarcinoma or alarming symptoms;
* Patients with a history of inflammatory bowel disease;
* Patients with mental illness or severe functional disorder who cannot cooperate with colonoscopy;
* Patients with severe cardiopulmonary insufficiency;
* Patients with severe coagulation disorders or high bleeding risk (platelets \<50×10⁹/L, INR \>1.5; discontinuation of antithrombotic drugs should follow the 2012 Japanese Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment and the2017 Appendix on Anticoagulants Including Direct Oral Anticoagulants;
* Patients with severe electrolyte imbalances;
* Patients with acute peritonitis or suspected intestinal perforation;
* Patients with toxic megacolon;
* Patients with stage 3 or higher hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
* Patients with untreated severe abdominal hernia, intestinal obstruction;
* Patients with intestinal strictures of any cause;
* Pregnancy and lactation.

Locations (1)

Xi'an, Shaanxi, China