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Combined Oral and Parenteral Nutritional Therapy After Gastrectomy for Gastric Cancer (BRIDGE-GC)

17. maj 2026 opdateret af: Kyo Young Song

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

55

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydkorea
    • Seoul
      • Seoul, Seoul, Sydkorea, 06591
        • Seoul St. Mary's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Combined Nutritional Therapy
Patients received combined oral nutritional supplementation and parenteral nutritional support during the postoperative recovery period after gastrectomy for gastric cancer.
Kosttilskud: Oral Nutritional Supplementation
Patients received oral nutritional supplementation using Encover® three times daily during the postoperative recovery period after gastrectomy for gastric cancer.
Andet: Parenteral Nutrition
Supplemental parenteral nutrition was administered during hospitalization and after discharge to support postoperative nutritional requirements.
Aktiv komparator: Standard Postoperative Care
Patients received standard postoperative nutritional management according to institutional clinical pathways after gastrectomy for gastric cancer.
Andet: Standard Postoperative Nutritional Care
Standard postoperative nutritional management according to institutional clinical pathways, including routine postoperative diet advancement and conventional nutritional support.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Body Weight Change
Tidsramme: 4 weeks after surgery
Difference between preoperative body weight and body weight measured at 4 weeks after gastrectomy for gastric cancer.
4 weeks after surgery

Sekundære resultatmål

Resultatmål
Tidsramme
Body Mass Index Change
Tidsramme: 4 weeks after surgery
4 weeks after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kyo Young Song

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2020

Primær færdiggørelse (Faktiske)

31. maj 2024

Studieafslutning (Faktiske)

31. maj 2024

Datoer for studieregistrering

Først indsendt

17. maj 2026

Først indsendt, der opfyldte QC-kriterier

17. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • XC17MCDI0065

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Mavekræft (GC)

Kliniske forsøg med Oral Nutritional Supplementation

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Kosttilskud

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