The Incidence of Gallstones After Gastrectomy

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965466
• Other study ID #: GGBS
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: August 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: Wenbo Meng, M.D.
• Phone: 13919177177
• Email: mengwb[@]lzu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 504
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstone
• Gallstones
• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Distal gastrectomy and radical resection
Distal gastrectomy and Roux-en-Y anastomosis
• Total gastrectomy and radical resection
Total gastrectomy and Roux-en-Y anastomosis

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu
China	Wuwei Tumor Hospital	Wuwei	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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