The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Incidence of Gallstones After Gastrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05965466
Recruitment Status : Recruiting
First Posted : July 28, 2023
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To provide preventive and therapeutic strategies for participants with gallstones after gastric cancer by comparing the risk of postoperative gallbladder stone formation with two different resection ranges using the Roux-en-Y reconstruction modality in radical gastric cancer surgery.

Condition or disease Intervention/treatment Phase
Gallstone Gastric Cancer Procedure: Distal gastrectomy and radical resection Procedure: Total gastrectomy and radical resection Not Applicable

Detailed Description:
A large number of clinical studies have found that the incidence of gallstones in patients after radical gastric cancer surgery is higher than that in the normal population. However, the pathogenesis has not been clarified, and the prophylactic removal of the gallbladder in patients with gastric cancer remains controversial. A previous study found a statistically significant incidence of gallbladder stones after Billroth I versus Roux-en-Y in distal gastrectomy for gastric cancer. Therefore, the investigators plan to conduct a retrospected cohort study to collect further participants with gastric cancer who underwent total gastrectomy to answer whether different surgical resection ranges during surgery increase the incidence of gallstones this question.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Distal gastrectomy and Total gastrectomy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Gastric Cancer Surgical Resection Extent on Postoperative Gallstone Formation: A Retrospected Cohort Study
Actual Study Start Date : July 21, 2023
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Distal gastrectomy
Distal subtotal gastrectomy was performed after exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by residual gastrojejunal Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo.
 Procedure: Distal gastrectomy and radical resection
Distal gastrectomy and Roux-en-Y anastomosis
Sham Comparator: Total gastrectomy
Total gastrectomy was performed after the exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by oesophageal jejunum Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo.
 Procedure: Total gastrectomy and radical resection
Total gastrectomy and Roux-en-Y anastomosis


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of gallstone patients [ Time Frame: 5years ]
    Two groups of patients with gastric cancer had a follow-up for more than one year and the number of patients with gallbladder stones on B-ultrasound or Computed Tomography (CT)


Secondary Outcome Measures :
  1. Number of patients with postoperative complications [ Time Frame: 5years ]
    The number of patients with postoperative complications such as abdominal haemorrhage, fistula, nausea, vomiting, abdominal infection and incision infection in 2 groups of gastric cancer patients

  2. Number of patients with bile duct stones [ Time Frame: 5years ]
    Two groups of patients with gastric cancer had a follow-up for more than one year. Clinical signs such as Charcot's triad and ultrasound, Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) show the number of patients with bile duct stones


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Gastric Cancer underwent Gastrectomy

Exclusion Criteria:

  • Age less than 18 years or age greater than 75 years;
  • Not Roux-en-Y reconstruction;
  • R0 excision is not achieved;
  • Previous history of upper abdominal surgery, such as cholecystectomy, gastrectomy;
  • Preoperative gallbladder diseases, such as gallstones, gallbladder polyps, chronic cholecystitis;
  • Preoperative neoadjuvant chemotherapy or radiotherapy;
  • Previous history of malignant tumours;
  • Patients with mental or developmental abnormalities or women during pregnancy or breastfeeding;
  • Gastric perforation or bleeding leading to emergency surgery;
  • Palliative surgical treatment;
  • Incomplete case information.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05965466


Contacts
Layout table for location contacts
Contact: Wenbo Meng, M.D. 13919177177 mengwb@lzu.edu.cn
Contact: Baoping Zhang, M.D. +8613893454820 zhangbp21@lzu.edu.cn

Locations
Layout table for location information
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 Tumor Hospital Recruiting
Wuwei, Gansu, China, 733099
Contact: Peng Nie, M.D.    +8615294333003    nie.peng2008@163.com   
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
Investigators
Layout table for investigator information
Principal Investigator: Wenbo Meng, M.D. Hepatopancreatobiliary Surgery Institute of Gansu Province
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Wenbo Meng, Director of Surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT05965466    
Other Study ID Numbers: GGBS
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Gallstone
Gastric Cancer
Gastrectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
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