Clinical Research Directory

Clinical Trial to Evaluate the Efficacy and Safety of SUBMO® as a Submucosal Injection Agent in Endoscopic Resection of Superficial Gastrointestinal Lesions.

The SUBMO-PIC01-2025 study evaluates whether SUBMO®, a submucosal injection hydrogel composed of high-molecular weight hyaluronic acid and methylene blue, is as effective and safe as normal saline for endoscopic resection of superficial colorectal lesions larger than 10 mm. Its primary aim is to determine non-inferiority in complete resection rates, whether en bloc or fragmented, and to assess safety through the systematic identification of serious adverse events. Secondary aims include analysing the total volume of product needed, the number of injections required, the maintenance of the submucosal cushion, the duration of the procedure, the ease of resection, the subjective evaluation of endoscopists, and the appearance of additional adverse events related to the intervention such as intraprocedural bleeding, fever, significant post-procedure pain, post-coagulation syndrome or immediate or delayed perforation. Eligible participants are adults aged 18 or older with a confirmed colorectal lesion greater than 10 mm that is technically resectable using EMR or ESD, who are capable and willing to follow the study procedures and who have signed informed consent prior to any protocol-specific action. Exclusion criteria include severe comorbidities corresponding to ASA IV or V unless specifically authorised by anaesthesia, coagulopathies that prevent endoscopic resection, endoscopic suspicion of invasive cancer, any condition deemed by investigators to compromise safety or adherence, known allergy to hyaluronic acid, methylene blue or excipients, contraindications to colonoscopy or sedation, participation in another clinical investigation within the previous 30 days, and pregnancy or breastfeeding. Participants may be withdrawn due to voluntary consent withdrawal, safety concerns, protocol deviations that affect data integrity or patient safety, loss to follow-up or pregnancy discovered during the study. The main efficacy variable is the technical success of resection as judged immediately by the endoscopist, while the main safety variable is the incidence of serious adverse events and their causal relationship with the investigational product. Exploratory variables include baseline demographics such as age, sex, ethnic origin and body mass index, anticoagulant or antiplatelet medication, and comorbidities including endoscopic history, obesity, hypertension, cardiovascular disease, haematologic disorders such as von Willebrand disease or haemophilia, and chronic liver disease. Baseline variables also include ASA classification and lifestyle habits. Polyp-related variables include size, number, anatomical location in the colon or rectum, LST subtype and JNET classification. Resection-related variables capture the technique used (EMR or ESD), whether the resection is en bloc or piecemeal, the number of fragments for calculating the Sydney Resection Quotient, the DMI score and any closure technique or complications. Treatment-related variables include total and per-surface area injection volume, number of submucosal injections needed, macroscopic evaluation of cushion maintenance, total procedure time, ease of resection using a visual analogue scale from 0 to 100, a usability questionnaire completed by the endoscopists and a detailed record of all adverse events including bleeding, fever, pain, post-coagulation syndrome and perforation.

COLO-PREDICT: Digital Training and Optical Diagnosis of Colorectal Polyps

Colorectal cancer prevention relies on high-quality colonoscopy and accurate optical characterization of colorectal polyps. Optical diagnosis may allow optimization of management strategies such as resect-and-discard for diminutive polyps, potentially improving efficiency in routine practice. COLO-PREDICT is a prospective, single-center, observational study designed to evaluate the impact of a structured digital training program (Colo-ID, a digital application for colonic polyp characterisation training) on the accuracy of optical histology prediction of colorectal polyps in real-life clinical practice. All consecutive adult patients undergoing colonoscopy with at least one detected polyp will be included. Optical prediction of polyp histology will be recorded during the procedure. All polyps will be resected and sent for histopathological analysis according to standard practice. No modification of patient management will occur as part of the study. The primary objective is to assess the concordance between optical prediction and histopathology before and after implementation of the digital training program. Secondary objectives include evaluation of prediction performance according to polyp characteristics and assessment of potential implications for clinical practice.

Impact of CADx on Endoscopists' Histologic Characterization of Diminutive Colorectal Polyps

This study evaluates the impact of CADx assistance on endoscopists' histologic characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. The primary objective is to determine whether CADx assistance increases the proportion of endoscopists who meet PIVI-related performance thresholds, thereby supporting implementation of the "resect and discard" and "diagnose and leave" strategies in routine clinical practice.

AI-Assisted Real-Time Endoscopic Characterization of Diminutive Colorectal Polyps in Non-Academic Hospitals

To validate the feasibility of promoting colorectal diminutive polyp "predict, resect, and discard" and "diagnose and leave" strategies for non-experts in general hospitals through CADx system.

Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size

A multicenter, randomized, parallel group, endoscopist blinded study to assess the diagnostic performance and sustainability of SCALE-EYE in a screening and surveillance colonoscopy population. Sustainability will be evaluated in terms of the reduction in colonoscopies, associated waste and carbon footprint.

Recurrence After Gastric and Intestinal Polyp Resection

This is a retrospective and prospective cohort study designed to evaluate the recurrence rate and identify risk factors after endoscopic resection of gastric and intestinal polyps. BACKGROUND: Gastric and intestinal polyps are common digestive diseases with potential for malignant transformation. Although endoscopic resection is the standard treatment, recurrence rates range from 10-50%, and the mechanisms and risk factors remain unclear. OBJECTIVES: Primary: To assess short-term (1-year) and long-term (3-year) recurrence rates after endoscopic polyp resection Secondary: To identify independent risk factors and develop a recurrence risk prediction model DESIGN: Mixed retrospective-prospective cohort study * Retrospective cohort: Patients who underwent polyp resection from 2021-2022, with follow-up data through 2024 * Prospective cohort: Patients enrolled from 2024-2025, with standardized follow-up through 2028 SETTING: Single tertiary referral center with \>10,000 endoscopic polyp resections performed since 2021 PARTICIPANTS: Approximately 1,600-1,800 adult patients (≥18 years) who underwent complete endoscopic resection of gastric or intestinal polyps FOLLOW-UP: * Short-term: 1 year post-resection (±2 months) * Long-term: 3 years post-resection (±3 months) MAIN OUTCOME: Recurrence rate defined as new polyp detection at original or different sites during endoscopic surveillance POTENTIAL RISK FACTORS: Patient demographics, polyp characteristics (size, number, location, pathology), resection method, Helicobacter pylori status, lifestyle factors, and medication use EXPECTED IMPACT: Results will inform personalized surveillance strategies and optimize resource allocation for post-polypectomy follow-up.

Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps

This was a non-inferiority randomized controlled trial designed to compare the efficacy and safety of cold versus hot snare polypectomy for the removal of 4-10 mm pedunculated colorectal polyps. The primary outcome was delayed postpolypectomy bleeding. The secondary outcomes included immediate postpolypectomy bleeding, procedure time, en bloc resection, complete histologic resection, use of haemostatic clips and perforation rate.

Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps

This study aims to evaluate the efficacy of Chanyanning granules in patients undergoing endoscopic resection of colorectal polyps with a basal diameter of 5-30 mm. From one day before the procedure to five days postoperatively, patients will be administered Chanyanning granules. The study will observe intraoperative and postoperative bleeding, perforation, and digestive system-related clinical symptoms such as postoperative abdominal pain, bloating, diarrhea, constipation, hematochezia, and fatigue, as well as related inflammatory markers, to determine the therapeutic effect of Chanyanning granules.

Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

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.

AI in Predicting Polyp Pathology and Endoscopic Classification

Background: Colonoscopy with optical diagnosis based on the appearance of polyps can guide the selection of endoscopic treatment methods, reduce unnecessary polypectomy procedures and the need for tissue pathological diagnosis, and formulate follow-up strategies in a timely manner \[1\]. This approach significantly alleviates the economic burden on patients and the healthcare system and can effectively ease the tension on clinical resources \[2\]. Various endoscopic polyp classification methods, including Pit Pattern \[3\], NICE \[4\], WASP \[5\], and MS \[6\], are used to determine pathological types. However, mastering these classification methods requires endoscopists to undergo extensive training, and due to the inherent flaws in each method, no single endoscopic classification method can accurately diagnose all types of polyps to meet the requirements of optical diagnosis. This limitation has hindered the widespread application of optical diagnosis in clinical practice \[7\]. The application of artificial intelligence technology in this field, known as computer-aided diagnosis (CADx), has seen rapid development in recent years. Numerous large-scale, prospective studies have demonstrated that the accuracy of CADx technology for optical diagnosis of minute lesions (\<5mm) has essentially met the threshold set by European and American endoscopy societies for optical diagnosis \[8,9\]. However, the diagnostic efficacy of CADx for polyps ≥5mm remains unclear. Moreover, current research is mostly limited to distinguishing between common adenomas and hyperplastic polyps, with little attention given to serrated lesions, which are also precancerous lesions and progress even more rapidly, and are more challenging for endoscopists to assess. These reasons prevent CADx from being widely applied in clinical practice for real-time accurate judgment of polyp pathological types.

6-year Follow-up Data After the Berberine Intervention Trial

Colorectal cancer (CRC) is a common malignancy of the digestive tract, which constitutes a major public health burden. Almost 90% of CRC cases progress from precursor adenomatous polyps through adenoma-carcinoma sequence. Endoscopic detection and removal of colorectal adenoma (CRA) could reduce the incidence and mortality risk of CRC, but the recurrence rate is still high. Therefore, chemoprevention is quite important, not only solve the urgent public health problem, but also be cost-effective. In 2020, the investigators published a multicenter, randomized, double-blind, placebo-controlled clinical study (NCT02226185) in the Lancet Gastroenterology \& Hepatology. The result concluded that oral BBR for 2 years significantly reduced recurrence after endoscopic removal of CRA (RR 0.77, 95%CI 0.66-0.91; p=0.001). BBR also has a significant preventive effect on all polypoid lesions, including adenomas and serrated lesions (adjusted RR 0.78, 95%CI 0.66-0.91; p=0.002) . Does BBR still have a long-term protective effect on the recurrence of CRA after discontinuation? That's what the investigators concerned. The present study is performed to observe and compare retrospectively the recurrence rate of CRAs in patients of the original BBR RCT study (NCT02226185) within 6 years after discontinuation of medication, including the overall recurrence rate of traditional adenomas within the first year, 1-3 years, 3-6 years, and the entire follow-up period of 6 years. The aim is to evaluate the long-term efficacy of BBR in preventing recurrence and carcinogenesis after endoscopic resection of CRAs.