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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05965466
Other study ID # GGBS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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