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Trial Title:
The Incidence of Gallstones After Gastrectomy
NCT ID:
NCT05965466
Condition:
Gallstone
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Gallstones
Cholelithiasis
Cholecystolithiasis
Conditions: Keywords:
Gallstone
Gastric Cancer
Gastrectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Distal gastrectomy and Total gastrectomy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Distal gastrectomy and radical resection
Description:
Distal gastrectomy and Roux-en-Y anastomosis
Arm group label:
Distal gastrectomy
Intervention type:
Procedure
Intervention name:
Total gastrectomy and radical resection
Description:
Total gastrectomy and Roux-en-Y anastomosis
Arm group label:
Total gastrectomy
Summary:
To provide preventive and therapeutic strategies for participants with gallstones after
gastric cancer by comparing the risk of postoperative gallbladder stone formation with
two different resection ranges using the Roux-en-Y reconstruction modality in radical
gastric cancer surgery.
Detailed description:
A large number of clinical studies have found that the incidence of gallstones in
patients after radical gastric cancer surgery is higher than that in the normal
population. However, the pathogenesis has not been clarified, and the prophylactic
removal of the gallbladder in patients with gastric cancer remains controversial. A
previous study found a statistically significant incidence of gallbladder stones after
Billroth I versus Roux-en-Y in distal gastrectomy for gastric cancer. Therefore, the
investigators plan to conduct a retrospected cohort study to collect further participants
with gastric cancer who underwent total gastrectomy to answer whether different surgical
resection ranges during surgery increase the incidence of gallstones this question.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with Gastric Cancer underwent Gastrectomy
Exclusion Criteria:
- Age less than 18 years or age greater than 75 years;
- Not Roux-en-Y reconstruction;
- R0 excision is not achieved;
- Previous history of upper abdominal surgery, such as cholecystectomy, gastrectomy;
- Preoperative gallbladder diseases, such as gallstones, gallbladder polyps, chronic
cholecystitis;
- Preoperative neoadjuvant chemotherapy or radiotherapy;
- Previous history of malignant tumours;
- Patients with mental or developmental abnormalities or women during pregnancy or
breastfeeding;
- Gastric perforation or bleeding leading to emergency surgery;
- Palliative surgical treatment;
- Incomplete case information.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hepatopancreatobiliary Surgery Institute of Gansu Province
Address:
City:
Lanzhou
Zip:
730000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbo Meng, MD,PhD
Phone:
+8613919177177
Email:
mengwb@lzu.edu.cn
Investigator:
Last name:
Wenbo Meng, MD,PhD
Email:
Principal Investigator
Facility:
Name:
Wuwei Tumor Hospital
Address:
City:
Wuwei
Zip:
733099
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Nie, M.D.
Phone:
+8615294333003
Email:
nie.peng2008@163.com
Start date:
July 21, 2023
Completion date:
January 1, 2024
Lead sponsor:
Agency:
Hepatopancreatobiliary Surgery Institute of Gansu Province
Agency class:
Other
Source:
Hepatopancreatobiliary Surgery Institute of Gansu Province
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05965466
