Jianpi Lishi Jiedu Granules for Prevention of Postoperative Recurrence in Colorectal Advanced Adenomas

Phase 3Not Yet RecruitingNCT07505056

Nanjing First Hospital, Nanjing Medical University376 enrolled

Overview

This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Jianpi Lishi Jiedu Granules in preventing postoperative recurrence of colorectal advanced adenoma. A total of 376 patients aged 18-80 years with endoscopically resected advanced adenoma and diagnosed with Spleen Deficiency and Dampness Toxin syndrome will be enrolled and randomly assigned to receive either Jianpi Lishi Jiedu Granules or placebo for 3 months. The primary endpoint is the adenoma recurrence rate at 1 year post-treatment, assessed by colonoscopy and pathological examination. Secondary endpoints include malignant transformation rate, TCM syndrome improvement, quality of life, gastrointestinal symptoms, and exploratory analyses of gut microbiota and inflammatory cytokines.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

376

Conditions

Colorectal Adenoma

Interventions

The intervention is orally administered as one sachet of Jianpi Lishi Jiedu Granules, twice daily (1 hour after breakfast and dinner), for a treatment course of 3 months. All participants will begin medication after resuming oral intake following surgery for colorectal advanced adenoma (≥2 weeks post-procedure).

Placebo granulesDRUG

Participants in the control group will receive placebo granules orally (with the same specifications, appearance, dosage, and administration as the experimental group) for a treatment course of 3 months. All participants will begin medication after resuming oral feeding following surgery for colorectal advanced adenoma (≥2 weeks post-procedure).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged between 18 and 80 years, male or female 2. Have undergone endoscopic resection of colorectal adenoma within the past 2 weeks (cold snare resection or endoscopic mucosal resection for adenomas \< 20 mm, or endoscopic submucosal dissection for adenomas ≥ 20 mm), and have been diagnosed with colorectal advanced adenoma by endoscopy and pathology 3. Traditional Chinese Medicine (TCM) syndrome type conforms to the Spleen Deficiency and Dampness Toxin syndrome 4. The patient is fully informed, voluntarily consents to data collection, and has signed the informed consent form Exclusion Criteria: 1. Patients with diseases such as familial polyposis, inflammatory bowel disease, serrated polyposis syndrome, Peutz-Jeghers syndrome, or other hereditary polyposis syndromes 2. Patients with long-term use of medications such as aspirin, metformin, intestinal flora regulators, folic acid, calcium preparations, and vitamin D 3. Patients with a bleeding tendency (referring to a pathological state where hemostasis is difficult after spontaneous bleeding or minor trauma due to coagulation dysfunction or vascular structural issues) or those currently using anticoagulant medications (e.g., aspirin, clopidogrel) 4. Patients in the active phase of inflammatory bowel disease (such as ulcerative colitis, Crohn's disease, etc.), with a history of intestinal bleeding, or a history of intestinal surgery 5. Patients with high-grade intraepithelial neoplasia involving the vascular system, lymphatic tumor thrombi, or small arteries; patients with biopsy pathology confirming suspected malignancy or established malignancy 6. Pregnant or lactating women, or patients planning a recent pregnancy 7. Patients with an allergic constitution or a history of allergies to multiple drugs 8. Patients with severe heart, brain, lung, liver, kidney diseases, or mental disorders who cannot tolerate colonoscopy, treatment, and clinical intervention 9. Patients currently participating in other clinical trials or those previously involved in trials related to this study.

Outcomes

Primary Outcomes

recurrence rate of colorectal advanced adenomas

Time frame: At 6 months and 1 year after treatment initiation

Secondary Outcomes

Number of Participants with Malignant Transformation and Interval Cancer

Time frame: At 6 months and 1 year after treatment initiation

Quality of Life (KPS Scale)

The Karnofsky Performance Status (KPS) Scale is a standardized tool used to assess the functional status and quality of life of patients. The scale ranges from 0 to 100, with higher scores indicating better quality of life. A score of 100 represents normal function with no complaints or evidence of disease, while a score of 0 indicates death. The interpretation of score changes is categorized as follows: significant improvement (KPS score increase of \>20 points), improvement (score increase of 10-20 points), stability (score change of \<10 points increase or decrease), and decline (score decrease of \>10 points). The score is rated by the investigator based on the patient's clinical status at each time point.

Time frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment

Total Score of the Gastrointestinal Symptom Rating Scale (GSRS)

The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item instrument used to assess gastrointestinal symptoms over the past week. The scale covers five symptom clusters: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is rated on a scale from 0 to 3, where 0 indicates no symptoms and 3 indicates severe symptoms. The total score ranges from 0 to 45, with higher scores indicating worse gastrointestinal symptoms (poorer outcome). The total score is calculated by summing the scores of all 15 items. The scale is administered by the investigator through patient interview at each specified time point.

Time frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment

Total Score of the Traditional Chinese Medicine (TCM) Syndrome Severity Scale

The TCM Syndrome Severity Scale is used to evaluate the severity of Spleen Deficiency and Dampness Toxin syndrome. The scale assesses five primary symptoms (abdominal distension and pain, constipation, diarrhea, poor appetite, dry mouth with sticky sensation) and four secondary symptoms (fatigue and laziness to speak, heavy sensation and drowsiness, nausea and vomiting tendency, borborygmus). Each symptom is rated on a 4-point scale: 0 (none), 1 (mild), 3 (moderate), and 5 (severe). The total score ranges from 0 to 45, with higher scores indicating more severe TCM syndrome symptoms (worse outcome). The total score is calculated by summing the scores of all nine items. The scale is administered by the investigator through patient interview and clinical assessment at each specified time point.

Time frame: Before treatment, 3 months after treatment, 6 months after treatment, 1 year after treatment

Number of Participants with Renal Impairment (Defined as Serum Creatinine Increase ≥50% from Baseline)

Renal impairment is defined as an increase in serum creatinine level of ≥50% from baseline. Serum creatinine is measured through routine biochemical testing, with units reported in μmol/L or mg/dL. Fasting venous blood samples are collected at baseline (before treatment), 3 months, 6 months, and 1 year after treatment. A participant is considered to have experienced renal impairment if the criterion is met at any of the scheduled visit time points. The final data will be reported as the number and percentage of participants who develop renal impairment.

Time frame: Baseline (before treatment), 3 months, 6 months, and 1 year after treatment

Jianpi Lishi Jiedu Granules for Prevention of Postoperative Recurrence in Colorectal Advanced Adenomas

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts