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Early warning of recurrence risk after NOTES Gallbladder Preserving Surgery based on serum bile acid profile

Early warning of recurrence risk after NOTES Gallbladder Preserving Surgery based on serum bile acid profile - Early warning of NOTES postoperative recurrence risk based on serum bile acid profile

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094465
Enrollment
Unknown
Registered
2024-12-23
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign gallbladder lesions

Interventions

Gallstone group (GS):None
Gallbladder Polyps group (GP):None
Gallstones combined with gallbladder polyps group (SP):None
Standardized treatment group for grade 1/2 patients:Standardized Ursodeoxycholic Acid Prophylactic Treatment for Half a Year
Standardized treatment group for grade 3/4 patients:Standardized Ursodeoxycholic Acid Prophylactic Treatment for One Year
Non standardized treatment group for grade 1/2 patients:Unsupervised Ursodeoxycholic Acid Prophylactic Treatment for Half a Year
Non standardized treatment group for grade 3/4 patients:Standardized Ursodeoxycholic Acid Prophylactic Treatment for One Year

Sponsors

The 909th hospital (Southeast Hospital of Xiamen University)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy Volunteers: 1) Volunteers with physical examination and no symptoms of disease; 2) The results of abdominal ultrasound showed that there was no abnormality in the hepatobiliary, pancreatic and spleen; 3) No other serious diseases; 4) Serum and fecal samples were collected at the time of enrollment and frozen at -80°C. Inpatients to be treated with NOTES cholecysticide: 1) A full set of blood biochemistry tests within one week before surgery; 2) Abdominal color ultrasound examination within three months before surgery, indicating gallstones or gallbladder polyps; 3) After NOTES chole-sparing therapy, it was determined that the lesion was gallstone or gallbladder polyp; 4) Serum and fecal samples were collected at the time of enrollment and frozen at -80°C. Follow-up patients who have undergone NOTES gallbladder-sparing therapy: 1) Abdominal ultrasound examination within three months before surgery, indicating gallstones or gallbladder polyps, and the postoperative lesions were confirmed to be gallstones or gallbladder polyps; 2) Agree and cooperate with the corresponding half a year or one year of ursodeoxycholic acid treatment according to the risk level of recurrence; 3) Agree and cooperate with the routine blood biochemical test before and after treatment, abdominal color ultrasound examination, and give blood samples and stool samples.

Exclusion criteria

Exclusion criteria: Healthy Controls: 1) Have obvious symptoms of disease; 2) Lack of abdominal color ultrasound results or suggestive of hepatobiliary, pancreatic and splenic abnormalities; 3) Have serious diseases, such as long-term hypertension, diabetes, liver cirrhosis, cancer, etc.; 4) No serum and stool samples were collected at the time of enrollment. Inpatients to be treated with NOTES cholecysticide: 1) No complete set of blood biochemical test reports within one week before surgery; 2) No abdominal ultrasound examination within three months before surgery; 3) Postoperative lesions are not gallstones or non-gallbladder polyps; 4) No serum and stool samples were collected at the time of enrollment. Follow-up patients who have undergone NOTES gallbladder-sparing therapy: 1) After surgery, it was clear that the lesions were non-gallstones and non-gallbladder polyps; 2) Unwilling or uncooperative to give ursodeoxycholic acid treatment for half a year or one year according to the risk level of gallstone or polyp recurrence; 3) Do not agree or cooperate with the pre-treatment and post-treatment routine blood biochemical tests, abdominal color ultrasound examination, and give blood specimens and stool specimens.

Design outcomes

Primary

MeasureTime frame
Total cholesterol (TC);Triglycerides (TG);Apolipoprotein A1 (APOA1);Apolipoprotein B (APOB);High density lipoprotein cholesterol (HDL-C);Low density lipoprotein cholesterol (LDL-C);Cholic acid (CA);Lithocholic acid (LCA);Deoxycholic acid (DCA);Ursodeoxycholic acid (UDCA);Chenodeoxycholic acid (CDCA);Taurocholic acid (TCA);Taurolithocholic acid (TLCA);Taurodeoxycholic acid (TDCA);Tauroursodeoxycholic acid (TUDCA);Taurochenodeoxycholic acid (TCDCA);Glycocholic acid (GCA);Glycolithocholic acid (GLCA);Glycodeoxycholic acid (GDCA);Glycochenodeoxycholic acid (GCDCA);Glycoursodeoxycholic acid (GUDCA);Abdominal ultrasound;

Countries

China

Contacts

Public ContactLixin Deng

The 909th hospital (Southeast Hospital of Xiamen University)

Lixdeng@hotmail.com+86 138 6083 5118

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026