The Incidence of Gallstones After Gastrectomy

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Completed

Conditions: Gallstone; Gastric Cancer

Treatments: Procedure: Total gastrectomy and radical resection; Procedure: Distal gastrectomy and radical resection

Study type: Interventional

Funder types: Other

Identifiers

NCT05965466

GGBS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 531 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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531 participants in 2 patient groups

Distal gastrectomy

Experimental group

Description:

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.

Treatment:

Procedure: Distal gastrectomy and radical resection

Total gastrectomy

Sham Comparator group

Description:

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.

Treatment:

Procedure: Total gastrectomy and radical resection