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Completed

NCT Number: NCT05965466

The Incidence of Gallstones After Gastrectomy

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province, Lanzhou, Gansu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Distal gastrectomy and radical resection

Procedure

Distal gastrectomy and Roux-en-Y anastomosis

Total gastrectomy and radical resection

Procedure

Total gastrectomy and Roux-en-Y anastomosis

Primary outcomes

  1. Number of gallstone patients

    Time frame: 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 outcomes

  1. Number of patients with postoperative complications

    Time frame: 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

  2. Number of patients with bile duct stones

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2023
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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