The Incidence of Gallstones After Gastrectomy

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

Effect of Gastric Cancer Surgical Resection Extent on Postoperative Gallstone Formation: A Retrospected Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

504

Phase

  • Not Applicable

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

Study Contact Backup

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, 733099
        • Recruiting
        • Wuwei Tumor Hospital
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5years
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
5years

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., 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)

July 21, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GGBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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