Totally Laparoscopic Distal Gastrectomy VS Pylorus-Preserving Gastrectomy for Early Gastric Cancer in the Middle Stomach

NCT06970327 | Completed DMC

• 2 other identifiers: ChangzhiMC202307Grant No. 2023MX009
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

With the development of laparoscopic technology, the surgical treatment of early gastric cancer (EGC) has shifted towards minimally invasive, precise, and function-preserving strategies. Totally laparoscopic distal gastrectomy (TLDG) and totally laparoscopic pylorus-preserving gastrectomy (TLPPG) are minimally invasive procedures. However, there is a lack of systematic evidence to directly compare their efficacies. This study focuses on two fully laparoscopic techniques, TLDG and TLPPG, to address two key objectives: (1) whether TLPPG can avoid the long-term functional sequelae of TLDG while ensuring oncological safety, including complications (delayed gastric emptying, reflux, and dumping syndrome), postoperative quality of life (assessed via the PGSAS-37 scale), and survival outcomes; and (2) the balance between complications and survival in function-preserving surgery. The findings aim to provide critical technical parameters for individualized surgical decision-making in EGC.

Conditions

Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Complications

  Incidence of postoperative complications classified by the Clavien-Dindo criteria, including rate of Infection, Anastomotic issues, and Delayed gastric emptying.

  From surgery completion to 30 days post - operation

Secondary Outcomes (11)

• Age

  Baseline

• Weight（Kilograms）

  Baseline

• Height（Centimeters）

  Baseline

• Body Mass Index (BMI)

  Baseline

• Blood Loss（Milliliters）

  Intraoperative

Study Arms (2)

TLPPG

Totally laparoscopic pylorus-preserving gastrectomy

TLDG

Totally laparoscopic distal gastrectomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

63 patients with TLDG and 32 with TLPPG were included. The two groups of patients had similar sex, age, body mass index (BMI), and preoperative hemoglobin and albumin levels.

You may qualify if:

• Preoperative diagnosis of early gastric adenocarcinoma (invasion limited to the mucosa or submucosa) confirmed by tissue biopsy, abdominal enhanced CT, and endoscopic ultrasound;
• Tumor located in the gastric body or distal stomach, \>4 cm from the pylorus;
• Ineligible for endoscopic mucosal dissection or elected for surgical treatment by family;
• Complete clinical and pathological data.

You may not qualify if:

• Severe anemia, coagulation disorders, or gastric outlet obstruction;
• History of gastric or upper abdominal surgery;
• Concurrent malignant tumors, ascites, edema, or pleural effusion;
• Gastric ulcers, polyps, or intestinal metaplasia.

Sponsors & Collaborators

• Changzhi Medical College: lead

Study Sites (1)

HeJi hospital affiliated ChangZhi medical college

Changzhi, Shanxi, 046000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 14, 2025
• Study Start: January 1, 2020
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)