The Incidence of Gallstones After Gastrectomy

NCT05965466 | Completed DMC

• 1 other identifier: GGBS
• Study Type: interventional
• Target: 531
• Locations: 1 country
• Sites: 2

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.

Conditions

Gallstone; Gastric Cancer

Keywords

Gallstone; Gastric Cancer; Gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of patients with postoperative complications

  5years

• Number of patients with bile duct stones

  5years

Study Arms (2)

Distal gastrectomy

EXPERIMENTAL

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

Total gastrectomy

SHAM COMPARATOR

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

Interventions

Distal gastrectomy and radical resection PROCEDURE

Distal gastrectomy and Roux-en-Y anastomosis

Distal gastrectomy

Total gastrectomy and radical resection PROCEDURE

Total gastrectomy and Roux-en-Y anastomosis

Total gastrectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Gastric Cancer underwent Gastrectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (2)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Wuwei Tumor Hospital

Wuwei, Gansu, 733099, China

Location

Related Publications (3)

• 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.

  PMID: 27433395 RESULT

• 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.

  PMID: 33205309 RESULT

• Zhang B, Nie P, Lin Y, Ma Z, Ma G, Wang Y, Ma Y, Zhao J, Zhang J, Yue P, Jiang N, Zhang X, Tian L, Lu L, Yuan J, Meng W. High incidence of gallstones after Roux-en-Y reconstruction gastrectomy in gastric cancer: a multicenter, long-term cohort study. Int J Surg. 2024 Apr 1;110(4):2253-2262. doi: 10.1097/JS9.0000000000001136.

  PMID: 38320088 DERIVED

MeSH Terms

Conditions

Gallstones; Stomach Neoplasms

Interventions

Gastroenterostomy

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Wenbo Meng, M.D.

  Hepatopancreatobiliary Surgery Institute of Gansu Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Surgery

Model Details: Distal gastrectomy and Total gastrectomy

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: July 21, 2023
• Primary Completion: November 16, 2024
• Study Completion: November 16, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)