Back to resultsThe Incidence of Gallstones After Gastrectomy
Primary Purpose
Gallstone, Gastric Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Distal gastrectomy and radical resection
Total gastrectomy and radical resection
Sponsored by
About this trial
This is an interventional treatment trial for Gallstone focused on measuring Gallstone, Gastric Cancer, Gastrectomy
Eligibility 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.
Sites / Locations
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceRecruiting
- Wuwei Tumor HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Distal gastrectomy
Total gastrectomy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of gallstone patients
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
Number of patients with postoperative complications
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
Number of patients with bile duct stones
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
Full Information
NCT ID
NCT05965466
First Posted
July 20, 2023
Last Updated
August 9, 2023
Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
1. Study Identification
Unique Protocol Identification Number
NCT05965466
Brief Title
The Incidence of Gallstones After Gastrectomy
Official Title
Effect of Gastric Cancer Surgical Resection Extent on Postoperative Gallstone Formation: A Retrospected Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstone, Gastric Cancer
Keywords
Gallstone, Gastric Cancer, Gastrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Distal gastrectomy and Total gastrectomy
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
504 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Distal gastrectomy
Arm Type
Experimental
Arm Description
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.
Arm Title
Total gastrectomy
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Distal gastrectomy and radical resection
Intervention Description
Distal gastrectomy and Roux-en-Y anastomosis
Intervention Type
Procedure
Intervention Name(s)
Total gastrectomy and radical resection
Intervention Description
Total gastrectomy and Roux-en-Y anastomosis
Primary Outcome Measure Information:
Title
Number of gallstone patients
Description
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)
Time Frame
5years
Secondary Outcome Measure Information:
Title
Number of patients with postoperative complications
Description
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
Time Frame
5years
Title
Number of patients with bile duct stones
Description
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
Time Frame
5years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbo Meng, M.D.
Phone
13919177177
Email
mengwb@lzu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Baoping Zhang, M.D.
Phone
+8613893454820
Email
zhangbp21@lzu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenbo Meng, M.D.
Organizational Affiliation
Hepatopancreatobiliary Surgery Institute of Gansu Province
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hepatopancreatobiliary Surgery Institute of Gansu Province
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbo Meng, MD,PhD
Phone
+8613919177177
Email
mengwb@lzu.edu.cn
First Name & Middle Initial & Last Name & Degree
Wenbo Meng, MD,PhD
Facility Name
Wuwei Tumor Hospital
City
Wuwei
State/Province
Gansu
ZIP/Postal Code
733099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Nie, M.D.
Phone
+8615294333003
Email
nie.peng2008@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27433395
Citation
Park DJ, Kim KH, Park YS, Ahn SH, Park do J, Kim HH. Risk Factors for Gallstone Formation after Surgery for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):98-104. doi: 10.5230/jgc.2016.16.2.98. Epub 2016 Jun 24.
Results Reference
result
PubMed Identifier
33205309
Citation
Wu CH, Huang KH, Chen MH, Fang WL, Chao Y, Lo SS, Li AF, Wu CW, Shyr YM. Comparison of the Long-term Outcome Between Billroth-I and Roux-en-Y Reconstruction Following Distal Gastrectomy for Gastric Cancer. J Gastrointest Surg. 2021 Aug;25(8):1955-1961. doi: 10.1007/s11605-020-04867-1. Epub 2020 Nov 17.
Results Reference
result
Learn more about this trial
The Incidence of Gallstones After Gastrectomy
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