Clinical trial NCT05965466: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gallstone
Gastric Cancer
Keywords: Gallstone
Gastric Cancer
Gastrectomy
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 531
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Distal gastrectomy and Total gastrectomy
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of gallstone patients
timeFrame: 5years
Secondary outcomes:
measure: Number of patients with postoperative complications
timeFrame: 5years
measure: Number of patients with bile duct stones
timeFrame: 5years
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
city: Wuwei
country: China
facility: Wuwei Tumor Hospital
state: Gansu
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Wenbo Meng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.