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Completed

NCT Number: NCT06970327

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

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HeJi hospital affiliated ChangZhi medical college

Changzhi, Shanxi, 046000, China

About this study

With the continuous advancement and innovation of laparoscopic technology, the surgical treatment paradigm for early gastric cancer (EGC) is undergoing a profound transformation, gradually evolving towards a more minimally invasive, precise, and function-preserving approach. In this context, Totally Laparoscopic Distal Gastrectomy (TLDG) and Totally Laparoscopic Pylorus-Preserving Gastrectomy (TLPPG) have emerged as two highly representative minimally invasive surgical procedures. Characterized by smaller incisions, reduced trauma, and relatively faster postoperative recovery, they have garnered extensive attention in the field of EGC treatment. However, despite their application in clinical practice, there is currently a lack of comprehensive and systematic evidence-based medical data that can directly and thoroughly compare their therapeutic effects.

This study will focus on these two advanced laparoscopic surgical techniques, TLDG and TLPPG, and conduct in-depth exploration around two core objectives. Firstly, it will evaluate whether TLPPG can effectively avoid the long-term functional sequelae potentially caused by TLDG while ensuring oncological safety. These sequelae include common complications such as delayed gastric emptying, reflux, and dumping syndrome. Additionally, the study will comprehensively assess patients' postoperative quality of life using the PGSAS-37 scale and further analyze the impact of the two surgical procedures on patients' survival outcomes. Secondly, it will delve into how to achieve the optimal balance between complication control and patients' survival benefits in function-preserving surgeries. Through rigorous data analysis and scientific demonstration, this study aims to provide crucial technical parameters and reliable decision-making bases for the formulation of personalized surgical plans for EGC patients, thereby promoting the development of minimally invasive treatment for early gastric cancer towards a more precise and efficient direction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Complications

    Time frame: From surgery completion to 30 days post - operation

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

Secondary outcomes

  1. Age

    Time frame: Baseline

    The age of the patient at the time of enrollment in the study.

  2. Weight(Kilograms)

    Time frame: Baseline

    The weight of the patient.

  3. Height(Centimeters)

    Time frame: Baseline

    The height of the patient.

  4. Body Mass Index (BMI)

    Time frame: Baseline

    The body mass index of the patient, calculated as weight (kg) divided by height squared (m²).

  5. Blood Loss(Milliliters)

    Time frame: Intraoperative

    The total volume of blood lost during the surgical procedure.

  6. Operation Time(Minutes)

    Time frame: Intraoperative

    The total duration of the surgical procedure.

  7. Number of Examined Lymph Nodes

    Time frame: Intraoperative

    The total number of lymph nodes examined during the surgical procedure.

  8. Time to Flatus

    Time frame: Perioperative

    The time elapsed from the end of the surgery until the patient experiences the first flatus.

  9. Time to Defecation

    Time frame: Perioperative

    The time elapsed from the end of the surgery until the patient has the first bowel movement.

  10. Time to Bite & Sup

    Time frame: Perioperative

    The time elapsed from the end of the surgery until the patient is able to eat and drink normally.

  11. Hospital Stay Duration

    Time frame: Perioperative

    The total number of days the patient remains hospitalized after the surgical procedure.

Sponsors and collaborators

Lead sponsor

Changzhi Medical College

Other

Registry information

Official study title

Comparative Study on the Efficacy of Totally Laparoscopic Distal Gastrectomy and Pylorus-Preserving Gastrectomy for Early Gastric Cancer in the Middle Stomach

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

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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