The Incidence of Gallstones After Gastric Cancer Surgery

NCT04250402 | Completed DMC

• 1 other identifier: Gallstones after gastrectomy
• Study Type: observational
• Target: 1,019
• Locations: 1 country
• Sites: 2

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.

Conditions

Gallstones; Gastric Cancer

Keywords

Gallstones; Gastric cancer; Gastrectomy; ESD; Vagus nerve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of malignant metastasis

  3 years

• Number of short-term deaths

  3 months

• Number of physical regurgitation, nausea, vomiting, diarrhea, constipation

  3 years

Study Arms (4)

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

Procedure: 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.

Procedure: 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.

Procedure: Resection

Arm 4

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

Procedure: Resection

Interventions

Resection PROCEDURE

Radical resection.

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Gastric cancer patients

You may qualify if:

• Gastric cancer patients
• Age from over 18 to under 75 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (2)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Wuwei turmour hospital

Wuwei, Gansu, 733000, China

Location

Related Publications (2)

• 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.

  PMID: 27433395 BACKGROUND

• 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.

  PMID: 29127549 BACKGROUND

MeSH Terms

Conditions

Gallstones; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Wenbo Meng, M.D., Ph. D.

  Hepatopancreatobiliary Surgery Institute of Gansu Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Direct of surgery

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: February 14, 2020
• Primary Completion: November 16, 2024
• Study Completion: November 16, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

CN (2)