Clinical trial NCT04250402: The Incidence of Gallstones After Gastric Cancer Surgery
Official title: The Incidence Risks of Gallstones After Radical Surgery in Different Types of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallstones
Gastric Cancer
Keywords: Gallstones
Gastric cancer
Gastrectomy
ESD
Vagus nerve
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 1019
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gastric cancer patients

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of gallstone patients
timeFrame: 3 years
Secondary outcomes:
measure: Number of malignant metastasis
timeFrame: 3 years
measure: Number of short-term deaths
timeFrame: 3 months
measure: Number of physical regurgitation, nausea, vomiting, diarrhea, constipation
timeFrame: 3 years
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
city: Wuwei
country: China
facility: Wuwei turmour hospital
state: Gansu
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Wenbo Meng, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.