The Incidence of Gallstones After Gastric Cancer Surgery

NCT ID: NCT04250402

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1019 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-14
• Study Completion Date: 2024-11-16

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.

Conditions

Gallstones; Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Arm 1

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

Resection

Intervention Type: PROCEDURE

Radical resection.

Arm 2

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.

Resection

Intervention Type: PROCEDURE

Radical resection.

Arm 3

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

Resection

Intervention Type: PROCEDURE

Radical resection.

Arm 4

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

Resection

Intervention Type: PROCEDURE

Radical resection.

Interventions

Resection

Radical resection.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Wenbo Meng

Direct of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenbo Meng, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, China

Wuwei turmour hospital

Wuwei, Gansu, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 27433395 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29127549 (View on PubMed)

Other Identifiers

Gallstones after gastrectomy

Identifier Type: -

Identifier Source: org_study_id