NCT02815150

Brief Summary

This study aims to assess the impact of preoperative oral carbohydrate drink on gastric emptying and PH of gastric fluid in gastric cancer patients directly. Furthermore, investigators aim to evaluate the safety and effectiveness of preoperative oral carbohydrate in elective gastric cancer surgery, providing direct evidence for clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2019

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

March 4, 2025

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

June 5, 2016

Last Update Submit

February 28, 2025

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • preoperative gastric residual volume of gastric fluid

    After anesthesia induction with 100-120mg propofol and 0.5 mg/kg rocuronium bromide and tracheal intubation, keep the patient in left lateral decubitus position. Insert the gastroscope ( Olympus 260) and perform complete suction of gastric fluid under direct vision with the suction apparatus connecting to the sterile airtight collector. Measure the volume of the gastric fluid in collector with a cylindrical measuring cup, accurate to 0.1ml. Repeat it and then take an average.

    20-30 minutes before the surgery

Secondary Outcomes (8)

  • Preoperative PH of gastric fluid

    20-30 minutes before the surgery

  • Preoperative thirsty/hungry scoring

    1 hour before the surgery

  • Rate of perioperative complications

    7-8 days

  • Recovery of bowel function

    3-7 days

  • Perioperative insulin sensitivity

    8 days

  • +3 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

Preoperative oral carbohydrate drink: patients drink 5% glucose solution 250ml 2-3 hours before surgery.

Dietary Supplement: preoperative oral carbohydrate drink

Control group

NO INTERVENTION

Patients undergo 6-8 hours of preoperative fasting.

Interventions

preoperative oral carbohydrate drinkDIETARY_SUPPLEMENT

5% glucose solution 250ml 2-3 hours before surgery

Treatment group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 years
  • Histologically confirmed gastric adenocarcinoma
  • Tumor of cT2-4aN0-2 in preoperative gastroscopy, endoscopic ultrasound, and/or abdominal computed tomography
  • Fit for elective radical resection
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • American Society of Anesthesiology (ASA) status I to III
  • Body mass index (BMI) of 17.5-27.5 kg/m2 .Patient agreed to participate this trial through informed consent.

You may not qualify if:

  • Symptoms of pyloric obstruction
  • Impaired bowel function, using drugs disturbing gastric secretion and gastric emptying
  • History of gastric resection
  • History of gastric cancer treatment
  • History of major abdominal operation, or diffuse peritonitis
  • Diabetes or impaired glucose tolerance, or with abnormality in other endocrine hormones
  • Potential difficult airway as evaluated by anesthesiologist
  • Pregnancy or breastfeeding were excluded in this trial .Patients would also be excluded if the following circumstances occurred: (1) failure of endotracheal intubation; (2) failure of intra-operative gastroscopy; or (3) irresectable tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Dongjie Yang

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 5, 2016

First Posted

June 28, 2016

Study Start

April 1, 2016

Primary Completion

January 6, 2019

Study Completion

January 30, 2019

Last Updated

March 4, 2025

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)