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NCT Number: NCT04250402

The Incidence of Gallstones After Gastric Cancer Surgery

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province, Lanzhou, Gansu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resection

Procedure

Radical resection.

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of malignant metastasis

    Time frame: 3 years

    Number of malignant metastases after radical gastrectomy in surgery methods of gastric cancer patients

  2. 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. 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

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2020
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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