The Incidence of Gallstones After Gastrectomy

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05965466

Collaborator

(none)

450

Enrollment

Locations

Arms

5.4

Anticipated Duration (Months)

225

Patients Per Site

41.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gallstone Gastric Cancer	Procedure: Distal gastrectomy and radical resection Procedure: Total gastrectomy and radical resection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Distal gastrectomy and Total gastrectomyDistal gastrectomy and Total gastrectomy

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 21, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Distal gastrectomy 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.	Procedure: Distal gastrectomy and radical resection Distal gastrectomy and Roux-en-Y anastomosis
Sham Comparator: Total gastrectomy 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.	Procedure: Total gastrectomy and radical resection Total gastrectomy and Roux-en-Y anastomosis

Arm

Intervention/Treatment

Experimental: Distal gastrectomy

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.

Procedure: Distal gastrectomy and radical resection

Distal gastrectomy and Roux-en-Y anastomosis

Sham Comparator: Total gastrectomy

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.

Procedure: Total gastrectomy and radical resection

Total gastrectomy and Roux-en-Y anastomosis

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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;
History of Endoscopic Submucosal Dissection (ESD) or Endoscopic Mucosal Resection (EMR);
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.