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NCT Number: NCT07604857

Combined Oral and Parenteral Nutritional Therapy After Gastrectomy for Gastric Cancer

Patients undergoing gastrectomy for gastric cancer frequently experience insufficient oral intake during the postoperative recovery period because of reduced gastric capacity, early satiety, and gastrointestinal symptoms. Although oral nutritional supplements (ONS) are commonly recommended, adherence is often poor, resulting in a postoperative nutritional gap.

This prospective randomized clinical trial was designed to evaluate the impact of combined oral and parenteral nutritional therapy on nutritional status and recovery after gastrectomy for gastric cancer. Patients were randomized to either a combined nutritional therapy group receiving oral nutritional supplementation plus parenteral nutrition or a control group receiving standard postoperative care.

The primary endpoint was postoperative body weight change at 4 weeks after surgery. Secondary endpoints included body composition, nutritional intake, inflammatory and immune markers, laboratory parameters, and quality of life outcomes.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

About this study

Postoperative nutritional deterioration remains a major clinical challenge after gastrectomy for gastric cancer. Reduced gastric capacity and postoperative gastrointestinal symptoms frequently result in inadequate oral intake during the early recovery period. Although oral nutritional supplements are widely recommended, adherence is often poor, potentially leading to insufficient caloric intake and postoperative nutritional deficits.

This prospective randomized clinical trial evaluates whether combined oral and parenteral nutritional therapy can improve postoperative nutritional status and recovery compared with standard postoperative care. Patients undergoing curative gastrectomy for gastric cancer are randomized to receive either combined oral nutritional supplementation plus parenteral nutrition or standard postoperative nutritional management.

Nutritional outcomes including body weight, body mass index, body composition, inflammatory markers, laboratory nutritional parameters, caloric intake, oral nutritional supplement adherence, and quality of life are assessed during the postoperative recovery period.

This study aims to clarify the clinical significance of supplemental parenteral nutrition in bridging the postoperative nutritional gap after gastrectomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 20 to 80 years
  • Histologically confirmed gastric cancer
  • Scheduled for curative total or subtotal gastrectomy
  • Ability to tolerate oral intake
  • Residence within areas covered by home care services
  • Written informed consent

Exclusion criteria

  • Body mass index (BMI) ≥30 kg/m² or <18.5 kg/m²
  • Uncontrolled diabetes mellitus
  • Severe hepatic or renal dysfunction
  • Active malignancy other than gastric cancer
  • Previous chemotherapy or radiotherapy
  • Allergy to oral nutritional supplement products

Treatment and study plan

oral nutritional supplementation

Dietary Supplement

Patients received oral nutritional supplementation using Encover® three times daily during the postoperative recovery period after gastrectomy for gastric cancer.

Parenteral nutrition

Other

Supplemental parenteral nutrition was administered during hospitalization and after discharge to support postoperative nutritional requirements.

Standard Postoperative Nutritional Care

Other

Standard postoperative nutritional management according to institutional clinical pathways, including routine postoperative diet advancement and conventional nutritional support.

Primary outcomes

  1. Postoperative Body Weight Change

    Time frame: 4 weeks after surgery

    Difference between preoperative body weight and body weight measured at 4 weeks after gastrectomy for gastric cancer.

Secondary outcomes

  1. Body Mass Index Change

    Time frame: 4 weeks after surgery

Sponsors and collaborators

Lead sponsor

Kyo Young Song

Other

Registry information

Official study title

Bridging the Postoperative Nutritional Gap After Gastrectomy for Gastric Cancer: A Prospective Randomized Trial of Combined Oral and Parenteral Nutritional Therapy

Acronym: BRIDGE-GC

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 22, 2026
Registry last updated
May 22, 2026

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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