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The Incidence of Gallstones After Gastric Cancer Surgery

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ClinicalTrials.gov Identifier: NCT04250402
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province

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.

Condition or disease Intervention/treatment
Gallstones Gastric Cancer Procedure: Resection

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.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Incidence Risks of Gallstones After Radical Surgery in Different Types of Gastric Cancer
Actual Study Start Date : February 14, 2020
Estimated Primary Completion Date : February 10, 2021
Estimated Study Completion Date : February 10, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Gastric cancer patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250402


Contacts
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Contact: Wenbo Meng, M.D., Ph. D. +8613919177177 mengwb@lzu.edu.cn
Contact: Yongbin Lu, M.D., Ph. D. +8618152114880 luyb09@lzu.edu.cn

Locations
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China, Gansu
Hepatopancreatobiliary Surgery Institute of Gansu Province Recruiting
Lanzhou, Gansu, China, 730000
Contact: Wenbo Meng, MD,PhD    +8613919177177    mengwb@lzu.edu.cn   
Principal Investigator: Wenbo Meng, MD,PhD         
Wuwei turmour hospital Not yet recruiting
Wuwei, Gansu, China, 733000
Contact: Peng S Nie, M. D.    +8615294333003    nie.peng2008@163.com   
Contact: Linzhi Lu, M. D.    +8613659359016    lulinzhi2006@163.com   
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
Investigators
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Principal Investigator: Wenbo Meng, M.D., Ph. D. Hepatopancreatobiliary Surgery Institute of Gansu Province
Publications:
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Responsible Party: Wenbo Meng, Direct of surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT04250402    
Other Study ID Numbers: Gallstones after gastrectomy
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province:
Gallstones
Gastric cancer
Gastrectomy
ESD
Vagus nerve
Additional relevant MeSH terms:
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Stomach Neoplasms
Gallstones
Cholelithiasis
Cholecystolithiasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical