Gastric CancerNCT02815150
Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients
A study testing preoperative oral carbohydrate drink in people with Gastric Cancer, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- preoperative oral carbohydrate drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2016to 30 Jan 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Safety and Effectiveness of Oral Administration of 5% Glucose Solution 250ml 2-3 Hours Before Surgery in Gastric Cancer Patients for Elective Radical Resection
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.
Read the detailed description
In clinic, administration of oral carbohydrate 2-3 hours before surgery has been widely applied in elective colorectal surgery. However, no direct evidence has been showed that whether it is safe to do so in gastric cancer patients who are fit for elective radical gastric resection.
This study aims to discuss the impact and safety of oral administration of 5% glucose solution 250ml 2-3 hours before elective gastric cancer surgery. It is an equivalence study, which refers to a single-center, prospective, single blind, and randomized controlled study design. Eighty-eight patients with gastric adenocarcinoma are going to be enrolled in the study, who will be allocated into control or treatment group. Patients in control group follow the traditional routine of 6-8 hours preoperative fasting, while those in the treatment group will orally intake 250ml 5% glucose solution 2-3 hours before surgery. The primary end-point is the preoperative gastric residual volume. The secondary end-points include preoperative PH of gastric fluid, assessment of perioperative psychosomatic conditions, rate of perioperative complications, level of insulin sensitivity, recovery of bowel function, and the length of hospital stay, etc.
- Conditions
- Gastric Cancer
- Being tested
- preoperative oral carbohydrate drink
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative oral carbohydrate drinkDietary supplement
5% glucose solution 250ml 2-3 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Preoperative oral carbohydrate drink: patients drink 5% glucose solution 250ml 2-3 hours before surgery. Receives: Dietary Supplement: preoperative oral carbohydrate drink |
| Control group | No intervention | Patients undergo 6-8 hours of preoperative fasting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20-30 minutes before the surgery
Secondary outcomes (8)
Preoperative PH of gastric fluid
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. Inject 1ml clear gastric fluid into a vacuum drying tube by syringe and detect the PH value with the Delta 320 PH Detector twice and calculate the average value.
Measured: 20-30 minutes before the surgery
Preoperative thirsty/hungry scoring
Visual analogue scale with the score 0-10, 0 the least, 10 the most
Measured: 1 hour before the surgery
Rate of perioperative complications
Including surgery-specific complications, such as bleeding, anastomosis leakage, and non-surgery-specific ones, such as lung infection, urinary tract infection, etc.
Measured: 7-8 days
Recovery of bowel function
Record the time, by using postoperative days(POD), to first flatus, first stool and the time to endure semifluid diet
Measured: 3-7 days
Perioperative insulin sensitivity
Quantitative Insulin Sensitivity Check Index, QUICKI = 1/ [ log ( I0) + log (G0) ]，I0 is the fasting insulin value, G0 is the fasting blood glucose value。
Measured: 8 days
Length of hospital stay
Post operative hospital stay
Measured: 2-3 weeks
Readmission rate within 30 days post operation
Readmission for any reason within 30 days after the surgery.
Measured: 1 month after surgery
Reoperation rate within 30 days post operation
Reoperation that happens within 30 days after the primary surgery.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start1 Apr 2016
- Primary completion6 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of the Fourth Military Medical University, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Dongjie Yang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Dongjie Yang, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815150
- Sponsor's protocol ID
- 2016018
- Status last verified
- Jan 2019
- First submitted
- 5 Jun 2016
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Oral Administration of 5% Glucose Solution 250ml 2-3 Hours Before Surgery in Gastric Cancer Patients for Elective Radical Resection
- ClinicalTrials.gov ID
- NCT02815150
- Acronym / sponsor ID
- 2016018
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of the Fourth Military Medical University, First Affiliated Hospital of Guangxi Medical University
- Study start
- 1 Apr 2016
- Primary completion
- 6 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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.
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.
Detailed description
In clinic, administration of oral carbohydrate 2-3 hours before surgery has been widely applied in elective colorectal surgery. However, no direct evidence has been showed that whether it is safe to do so in gastric cancer patients who are fit for elective radical gastric resection.
This study aims to discuss the impact and safety of oral administration of 5% glucose solution 250ml 2-3 hours before elective gastric cancer surgery. It is an equivalence study, which refers to a single-center, prospective, single blind, and randomized controlled study design. Eighty-eight patients with gastric adenocarcinoma are going to be enrolled in the study, who will be allocated into control or treatment group. Patients in control group follow the traditional routine of 6-8 hours preoperative fasting, while those in the treatment group will orally intake 250ml 5% glucose solution 2-3 hours before surgery. The primary end-point is the preoperative gastric residual volume. The secondary end-points include preoperative PH of gastric fluid, assessment of perioperative psychosomatic conditions, rate of perioperative complications, level of insulin sensitivity, recovery of bowel function, and the length of hospital stay, etc.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Dietary Supplement: preoperative oral carbohydrate drinkPreoperative oral carbohydrate drink: patients drink 5% glucose solution 250ml 2-3 hours before surgery. |
| Control group | No intervention | –Patients undergo 6-8 hours of preoperative fasting. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| preoperative oral carbohydrate drink5% glucose solution 250ml 2-3 hours before surgery | Dietary supplement | Treatment group |
Primary outcome
preoperative gastric residual volume of gastric fluid
Time frame: 20-30 minutes before the surgery
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.
8 secondary outcomes
Preoperative PH of gastric fluid
Time frame: 20-30 minutes before the surgery
Preoperative thirsty/hungry scoring
Time frame: 1 hour before the surgery
Rate of perioperative complications
Time frame: 7-8 days
Recovery of bowel function
Time frame: 3-7 days
Perioperative insulin sensitivity
Time frame: 8 days
Length of hospital stay
Time frame: 2-3 weeks
Readmission rate within 30 days post operation
Time frame: 1 month after surgery
Reoperation rate within 30 days post operation
Time frame: 1 month 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 4 Mar 2025.
- 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.
Dongjie Yang principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative oral carbohydrate drink in people with Gastric Cancer, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 7 inclusion and 8 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 4 Mar 2025. 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 China. 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?
preoperative gastric residual volume of gastric fluid (time frame: 20-30 minutes before the 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 4 Mar 2025.