The Incidence of Gallstones After Gastric Cancer Surgery

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Completed

Conditions: Gallstones; Gastric Cancer

Treatments: Procedure: Resection

Study type: Observational

Funder types: Other

Identifiers

NCT04250402

Gallstones after gastrectomy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,019 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,019 participants in 4 patient groups

Arm 1

Description:

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

Treatment:

Procedure: Resection

Arm 2

Description:

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.

Treatment:

Procedure: Resection

Arm 3

Description:

Total gastrectomy with D2 lymphadenectomy will be performed with curative treated intent. The type of reconstruction will be with jejunal interposition reconstruction.

Treatment:

Procedure: Resection

Arm 4

Description:

Proximal gastrectomy with D2 lymphadenectomy. The type of reconstruction will be jejunal interposition with double anastomosis method.

Treatment:

Procedure: Resection