The Incidence of Gallstones After Gastrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

531 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-21

Study Completion Date

2024-11-16

Brief Summary

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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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Detailed Description

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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.

Conditions

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Gallstone Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Distal gastrectomy and Total gastrectomy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Distal gastrectomy and radical resection

Intervention Type PROCEDURE

Distal gastrectomy and Roux-en-Y anastomosis

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.

Group Type SHAM_COMPARATOR

Total gastrectomy and radical resection

Intervention Type PROCEDURE

Total gastrectomy and Roux-en-Y anastomosis

Interventions

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Distal gastrectomy and radical resection

Distal gastrectomy and Roux-en-Y anastomosis

Intervention Type PROCEDURE

Total gastrectomy and radical resection

Total gastrectomy and Roux-en-Y anastomosis

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No