The Incidence of Gallstones After Gastric Cancer Surgery

Gastric Cancer Clinical Trial

Official title:

The Incidence Risks of Gallstones After Radical Surgery in Different Types of Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04250402
• Other study ID #: Gallstones after gastrectomy
• Status: Recruiting
• Start date: February 14, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: Wenbo Meng, M.D., Ph. D.
• Phone: +8613919177177
• Email: mengwb[@]lzu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Through previous clinical observations and literature, we found that the incidence of gallstones in patients after gastric cancer radical resection was significantly higher than that in the normal population (4%). However, its pathogenesis has not been clarified. We compare the risk of gallbladder stones after four different radical gastric cancer surgical methods, in order to provide prevention and treatment strategies for people with gallstones after gastric cancer.

Description:

A large number of clinical studies have found that the incidence of gallstones in patients with radical gastric cancer is higher than that in the normal population. However, its pathogenesis has not been clarified, and there is still controversy about the prophylactic removal of gallbladder in patients with gastric cancer. The investigator's previous study found that there was no statistical difference in the incidence of gallstones after laparoscopic distal gastrectomy (LDG), laparoscopic total gastrectomy (LTG) and laparoscopic proximal gastrectomy (LPG). A common feature of the three surgical methods is that the vagus nerve were more or less cut during the operation. Therefore, we plan to further collect gastric cancer patients undergoing endoscopic submucosal dissection (ESD) surgery in order to answer whether the vagus nerve cut during surgery will increase the incidence of gallstones.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Gastric cancer patients

• Age from over 18 to under 75 years

Exclusion Criteria:

• Gallbladder disease before surgery

• Gallbladder has been remove

• History of previous upper abdominal surgery

• History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection

• History of other malignant disease within past five years

• History of previous neoadjuvant chemotherapy or radiotherapy

• History of unstable angina or myocardial infarction within past six months

• History of cerebrovascular accident within past six months

• Requirement of simultaneous surgery for other disease

• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

• Pregnant women or breastfeeding

• Unwillingness or inability to consent for the study

• Severe mental disorder

• Unstable vital signs Coagulation dysfunction (INR>1.5)

• Low peripheral blood platelet count (<50×10 ^9 / L) or using anti- coagulation drugs

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Resection
Radical resection.

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu
China	Wuwei turmour hospital	Wuwei	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (2)

Furukawa H, Ohashi M, Honda M, Kumagai K, Nunobe S, Sano T, Hiki N. Preservation of the celiac branch of the vagal nerve for pylorus-preserving gastrectomy: is it meaningful? Gastric Cancer. 2018 May;21(3):516-523. doi: 10.1007/s10120-017-0776-8. Epub 2017 Nov 10. — View Citation

Park DJ, Kim KH, Park YS, Ahn SH, Park do J, Kim HH. Risk Factors for Gallstone Formation after Surgery for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):98-104. doi: 10.5230/jgc.2016.16.2.98. Epub 2016 Jun 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of gallstone patients	Four different gastric cancer patients were followed up for more than 1 year. The number of patients with gallbladder stones revealed by B-ultrasound	3 years
Secondary	Number of malignant metastasis	Number of malignant metastases after radical gastrectomy in surgery methods of gastric cancer patients	3 years
Secondary	Number of short-term deaths	Number of short-term deaths after radical gastrectomy in surgery methods of gastric cancer patients	3 months
Secondary	Number of physical regurgitation, nausea, vomiting, diarrhea, constipation	The number of physical regurgitation, nausea, vomiting, diarrhea, constipation, and other events that affect quality of life in four surgery methods of gastric cancer patients	3 years