Neoplasms

All Conditions

Adenoma

Precancerous Conditions

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endoscopists in control group were informed standard quality indicators requirements and the corresponding references during informed consent.

Endoscopists in feedback group were informed standard quality indicators requirements and the corresponding references during informed consent. In addition to the quality requirements, endoscopists randomized to feedback group received customized quality reports feedback from Endo.Adm weekly.

Endoscopists received quality report generated by Endo.Adm.

Quality audit and feedback

Control

We intend to develop intelligent quality control and management software based on the work of digestive endoscopic artificial intelligence in the Department of Gastroenterology, Wuhan University Renmin Hospital, to accurately and comprehensively assess the quality of gastrointestinal endoscopy and to provide a practical basis for improving the quality of digestive endoscopy in our endoscopic center.

Endoscopic Quality Improvement System Study

A Prospective, Single-center Study Evaluating the Effectiveness of Endo.Adm in Improving the Quality of Gastrointestinal Endoscopy

Individual de-identified participant data that underlie the results reported in this article and study protocol will be shared for investigators whose proposed use of the data has been approved by an independent review committee. Data can only be used to achieve aims in the approved proposal. Data disclosure begins 9 months and ends 36 months after article publication. To gain access, data requesters will need to sign a data access agreement. Proposals should be directed to the corresponding author.

ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.

GPCs detection rate was calculated by dividing the total number of patients being detected gastric precancerous by the number of gastroscopies.

Adcanced ADR was calculated by dividing the total number of patients being detected ≥10mm in size, or adenomas with histopathology of tubulovillous, villous, adenocarcinoma, or high-grade dysplasia by the number of colonoscopies.

Renmin Hospital of Wuhan University

Micronutrients

Hematinics

All Drugs and Chemicals

Vitamins

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Experiment group: oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day, + oral administration of Folic Acid Tablet simulation half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.

Control group: oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day, + oral administration of folic acid tablets half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.

oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day

MoLuoDan

oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day

Sanchi powder

oral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day.

Folic Acid Tablet

oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day

MoLuoDan simulation

oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day

Sanchi powder simulation

oral administration of folic acid simulation tablets half a hour after meal for 5 mg each time for 3 times a day.

Folic Acid Tablet simulation

Xiangxue Ma, Doctor

Xiangxue Ma

This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology. Meanwhile, patients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic acid was used as the control. The therapeutic effect and safety of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from the points of view of pathology, gastroscopy and symptoms. The elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%. Moreover, high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which could form the mature, propagable and effective scheme.

Intraepithelial neoplasia of gastric mucosa is a well-recognized gastric Premalignant lesion, which is the key of secondary prevention for gastric cancer. However, no universally acknowledged effective therapeutic scheme is available at present. Previously, the investigator's research group has carried out clinical trial study based on solving the key problems such as diagnostic criteria, mucosal biopsy consistency and therapeutic evaluation methodology, and has attained certain achievements. This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology. Meanwhile, patients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic acid was used as the control. The therapeutic effect and safety of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from the points of view of pathology, gastroscopy and symptoms. The elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%. Moreover, high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which could form the mature, propagable and effective scheme. At the same time, molecular and biological indicators, including CDX2, SOX2, MUC2, MUC6, MUC5AC and CD10, were detected using the pathological tissues, so as to explore the therapeutic mechanism of Jianpi Huoxue Recipe in intervening gastric Premalignant lesion, and to construct the model platform for special disease research on gastric Premalignant lesion.

Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion

Therapeutic Mechanism of Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion：A Multi-center, Randomized and Controlled Experiment

The all patients' histopathology will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' histopathology should be evaluated for comparison between two groups,at the same time patients' histopathology should be evaluated for comparison in each group.The change in histological score (mean score of all biopsie after treatment in each group and between groups was calculated. The response rate of each pathological lesion was calculated as a percentage of those improved or disappeared at the 6th month to all subjects. The disappearance rate of dysplasia between groups were compared, which was defined as the absence of dysplasia (score 0) in all biopsy specimens after treatment.

The score changes of atrophy, intestinal metaplasia, chronic inflammation and active inflammation compared between baseline and after 6-month treatment.

The score changes of endoscopic findings, such as erosion, bleeding, coarse and uneven mucosa, and bile reflux were compared between baseline and after 6-month treatment.

Changes of symptom score were compared. The symptom include upper abdominal pain, upper abdominal distension, poor appetite, nausea and belching. The disappearance rate of symptom was expressed as a percentage of the subjects whose symptoms disappeared after medication to those exhibiting symptoms before medication.

The patient-reported outcome (PRO) instrument for chronic gastrointestinal diseases was a 35-item instrument, including 6 dimensions of regurgitation, dyspepsia, defecation, general condition, emotion and social function. All items graded into 5 levels and scored 0-4, except for decreased appetite, which is grouped into 4 levels and scored 0-3.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Endoscopic Quality Improvement System Study	NCT04654247	Adenoma Colon Gastric Precanc...	Quality audit a... Control	18 Years -	Renmin Hospital of Wuhan University
Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion	NCT03823248	Gastric Precanc...	MoLuoDan Sanchi powder Folic Acid Tabl... MoLuoDan simula... Sanchi powder s... Folic Acid Tabl...	18 Years - 75 Years	Xiyuan Hospital of China Academy of Chinese Medical Sciences

Spots Global Cancer Trial Database for gastric precancerous condition