The Incidence of Gallstones After Gastric Cancer Surgery
- Conditions
- GallstonesGastric Cancer
- Interventions
- Procedure: Resection
- Registration Number
- NCT04250402
- Lead Sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1019
- Gastric cancer patients
- Age from over 18 to under 75 years
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm 2 Resection Distal subtotal gastrectomy with D2 lymphadenectomy. After exclusion of T4b, bulky lymph nodes, or distant metastasis case, distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally. Arm 4 Resection Proximal gastrectomy with D2 lymphadenectomy. The type of reconstruction will be jejunal interposition with double anastomosis method. Arm 3 Resection Total gastrectomy with D2 lymphadenectomy will be performed with curative treated intent. The type of reconstruction will be with jejunal interposition reconstruction. Arm 1 Resection Endoscopic submucosal dissection. Endoscopic submucosal dissection is an endoscopic procedure which can achieve en bloc resection of GI tumor. ESD is characterized by three steps: injecting fluid into the submucosa to elevate the lesion from the muscle layer, circumferential cutting of the surrounding mucosa of the lesion, and subsequent dissection of the connective tissue of the submucosa beneath the lesion. The ESD procedure will be carried out by experienced endoscopists. Other Name: ESD
- Primary Outcome Measures
Name Time Method Number of gallstone patients 3 years Four different gastric cancer patients were followed up for more than 1 year. The number of patients with gallbladder stones revealed by B-ultrasound
- Secondary Outcome Measures
Name Time Method Number of malignant metastasis 3 years Number of malignant metastases after radical gastrectomy in surgery methods of gastric cancer patients
Number of physical regurgitation, nausea, vomiting, diarrhea, constipation 3 years 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
Number of short-term deaths 3 months Number of short-term deaths after radical gastrectomy in surgery methods of gastric cancer patients
Trial Locations
- Locations (2)
Hepatopancreatobiliary Surgery Institute of Gansu Province
🇨🇳Lanzhou, Gansu, China
Wuwei turmour hospital
🇨🇳Wuwei, Gansu, China