The Incidence of Gallstones After Gastrectomy

Not Applicable

Completed

• Conditions: Gallstone; Gastric Cancer

• Registration Number: NCT05965466
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

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.

Study Timeline

• Study First Submitted: 2023-07-20
• Study Start: 2023-07-21
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-07-28
• Status Verified: 2024-11
• Primary Completion: 2024-11-16
• Study Completion: 2024-11-16
• Last Update Submitted: 2024-11-16
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 531

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of gallstone patients	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

Name	Time	Method
Number of patients with bile duct stones	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
Number of patients with postoperative complications	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

Trial Locations

Locations (2)

Hepatopancreatobiliary Surgery Institute of Gansu Province; 🇨🇳 Lanzhou, Gansu, China

Wuwei Tumor Hospital; 🇨🇳 Wuwei, Gansu, China