The Incidence of Gallstones After Gastrectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gallstone, Gastric Cancer

Intervention / Treatment
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* Procedure: Distal gastrectomy and radical resection
* Procedure: Total gastrectomy and radical resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Distal gastrectomy and Total gastrectomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal gastrectomy<br>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<br>* Distal gastrectomy and Roux-en-Y anastomosis<br>|
| Sham Comparator: Total gastrectomy<br>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<br>* Total gastrectomy and Roux-en-Y anastomosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 5years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5years | 
| 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 | 5years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gallstone, Gastric Cancer, Gastrectomy