The Incidence of Gallstones After Gastric Cancer Surgery

October 9, 2023 updated by: Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province

The Incidence Risks of Gallstones After Radical Surgery in Different Types of Gastric Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yongbin Lu, M.D., Ph. D.
  • Phone Number: +8618152114880
  • Email: luyb09@lzu.edu.cn

Study Contact Backup

  • Name: Wenbo Meng, M.D., Ph. D.
  • Phone Number: +8613919177177
  • Email: mengwb@lzu.edu.cn

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Hepatopancreatobiliary Surgery Institute of Gansu Province
        • Principal Investigator:
          • Wenbo Meng, MD,PhD
        • Contact:
      • Wuwei, Gansu, China, 733000
        • Not yet recruiting
        • Wuwei turmour hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Gastric cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Procedure: Resection
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.
Procedure: Resection
Radical resection.
Arm 4
Proximal gastrectomy with D2 lymphadenectomy. The type of reconstruction will be jejunal interposition with double anastomosis method.
Procedure: Resection
Radical resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of gallstone patients
Time Frame: 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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of malignant metastasis
Time Frame: 3 years
Number of malignant metastases after radical gastrectomy in surgery methods of gastric cancer patients
3 years
Number of short-term deaths
Time Frame: 3 months
Number of short-term deaths after radical gastrectomy in surgery methods of gastric cancer patients
3 months
Number of physical regurgitation, nausea, vomiting, diarrhea, constipation
Time Frame: 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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Investigators

  • Principal Investigator: Wenbo Meng, M.D., Ph. D., Hepatopancreatobiliary Surgery Institute of Gansu Province

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2020

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gallstones after gastrectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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