Gastric Cancer (GC)BRIDGE-GCNCT07604857
Combined Oral and Parenteral Nutritional Therapy After Gastrectomy for Gastric Cancer
A study testing Oral Nutritional Supplementation, Parenteral Nutrition and Standard Postoperative Nutritional Care in people with Gastric Cancer (GC) and Malnutitrion, run by Kyo Young Song at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer (GC), Malnutitrion
- What is being tested?
- Oral Nutritional Supplementation, Parenteral Nutrition and Standard Postoperative Nutritional Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2020to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bridging the Postoperative Nutritional Gap After Gastrectomy for Gastric Cancer: A Prospective Randomized Trial of Combined Oral and Parenteral Nutritional Therapy
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.
Read the detailed description
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.
- Conditions
- Gastric Cancer (GC), Malnutitrion
- Being tested
- Oral Nutritional Supplementation, Parenteral Nutrition, Standard Postoperative Nutritional Care
- Keywords
- Gastrectomy, Parenteral Nutrition, Oral Nutritional Supplement, Postoperative Recovery, Nutritional Support, Body Weight Loss, Randomized Trial
- Medical subject headings
- Stomach Neoplasms, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutritional SupplementationDietary supplement
Patients received oral nutritional supplementation using Encover® three times daily during the postoperative recovery period after gastrectomy for gastric cancer.
Parenteral NutritionOther
Supplemental parenteral nutrition was administered during hospitalization and after discharge to support postoperative nutritional requirements.
Standard Postoperative Nutritional CareOther
Standard postoperative nutritional management according to institutional clinical pathways, including routine postoperative diet advancement and conventional nutritional support.
| Study group | Role | What they receive |
|---|---|---|
| Combined Nutritional Therapy | Experimental | Patients received combined oral nutritional supplementation and parenteral nutritional support during the postoperative recovery period after gastrectomy for gastric cancer. Receives: Dietary Supplement: Oral Nutritional Supplementation; Other: Parenteral Nutrition |
| Standard Postoperative Care | Active comparator | Patients received standard postoperative nutritional management according to institutional clinical pathways after gastrectomy for gastric cancer. Receives: Other: Standard Postoperative Nutritional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Body Weight Change
Difference between preoperative body weight and body weight measured at 4 weeks after gastrectomy for gastric cancer.
Measured: 4 weeks after surgery
Secondary outcomes (1)
Body Mass Index Change
Measured: 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Oct 2020
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to receive either combined oral and parenteral nutritional therapy or standard postoperative nutritional care after gastrectomy for gastric cancer.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyo Young Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyo Young Song, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604857
- Sponsor's protocol ID
- XC17MCDI0065
- Acronym
- BRIDGE-GC
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Postoperative Nutritional Gap After Gastrectomy for Gastric Cancer: A Prospective Randomized Trial of Combined Oral and Parenteral Nutritional Therapy
- ClinicalTrials.gov ID
- NCT07604857
- Acronym / sponsor ID
- BRIDGE-GC / XC17MCDI0065
- Conditions
- Gastric Cancer (GC), Malnutitrion
- Keywords
- Gastrectomy, Parenteral Nutrition, Oral Nutritional Supplement, Postoperative Recovery, Nutritional Support, Body Weight Loss, Randomized Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kyo Young SongUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to receive either combined oral and parenteral nutritional therapy or standard postoperative nutritional care after gastrectomy for gastric cancer.
| Arm | Type | Receives |
|---|---|---|
| Combined Nutritional Therapy | Experimental | Dietary Supplement: Oral Nutritional Supplementation, Other: Parenteral NutritionPatients received combined oral nutritional supplementation and parenteral nutritional support during the postoperative recovery period after gastrectomy for gastric cancer. |
| Standard Postoperative Care | Active comparator | Other: Standard Postoperative Nutritional CarePatients received standard postoperative nutritional management according to institutional clinical pathways after gastrectomy for gastric cancer. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Nutritional SupplementationPatients received oral nutritional supplementation using Encover® three times daily during the postoperative recovery period after gastrectomy for gastric cancer. | Dietary supplement | Combined Nutritional Therapy |
| Parenteral NutritionSupplemental parenteral nutrition was administered during hospitalization and after discharge to support postoperative nutritional requirements. | Other | Combined Nutritional Therapy |
| Standard Postoperative Nutritional CareStandard postoperative nutritional management according to institutional clinical pathways, including routine postoperative diet advancement and conventional nutritional support. | Other | Standard Postoperative Care |
Primary outcome
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.
1 secondary outcome
Body Mass Index Change
Time frame: 4 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutritional Supplementation, Parenteral Nutrition and Standard Postoperative Nutritional Care in people with Gastric Cancer (GC) and Malnutitrion, run by Kyo Young Song at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Body Weight Change (time frame: 4 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.