Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-18 @ 6:51 PM
Study NCT ID:
NCT02815150
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2016-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2016-06-05', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'preoperative gastric residual volume of gastric fluid', 'timeFrame': '20-30 minutes before the surgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Preoperative PH of gastric fluid', 'timeFrame': '20-30 minutes before the surgery', 'description': '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.'}, {'measure': 'Preoperative thirsty/hungry scoring', 'timeFrame': '1 hour before the surgery', 'description': 'Visual analogue scale with the score 0-10, 0 the least, 10 the most'}, {'measure': 'Rate of perioperative complications', 'timeFrame': '7-8 days', 'description': 'Including surgery-specific complications, such as bleeding, anastomosis leakage, and non-surgery-specific ones, such as lung infection, urinary tract infection, etc.'}, {'measure': 'Recovery of bowel function', 'timeFrame': '3-7 days', 'description': 'Record the time, by using postoperative days(POD), to first flatus, first stool and the time to endure semifluid diet'}, {'measure': 'Perioperative insulin sensitivity', 'timeFrame': '8 days', 'description': 'Quantitative Insulin Sensitivity Check Index, QUICKI = 1/ \\[ log ( I0) + log (G0) \\]，I0 is the fasting insulin value, G0 is the fasting blood glucose value。'}, {'measure': 'Length of hospital stay', 'timeFrame': '2-3 weeks', 'description': 'Post operative hospital stay'}, {'measure': 'Readmission rate within 30 days post operation', 'timeFrame': '1 month after surgery', 'description': 'Readmission for any reason within 30 days after the surgery.'}, {'measure': 'Reoperation rate within 30 days post operation', 'timeFrame': '1 month after surgery', 'description': 'Reoperation that happens within 30 days after the primary surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 80 years\n* Histologically confirmed gastric adenocarcinoma\n* Tumor of cT2-4aN0-2 in preoperative gastroscopy, endoscopic ultrasound, and/or abdominal computed tomography\n* Fit for elective radical resection\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* American Society of Anesthesiology (ASA) status I to III\n* Body mass index (BMI) of 17.5-27.5 kg/m2 .Patient agreed to participate this trial through informed consent.\n\nExclusion Criteria:\n\n* Symptoms of pyloric obstruction\n* Impaired bowel function, using drugs disturbing gastric secretion and gastric emptying\n* History of gastric resection\n* History of gastric cancer treatment\n* History of major abdominal operation, or diffuse peritonitis\n* Diabetes or impaired glucose tolerance, or with abnormality in other endocrine hormones\n* Potential difficult airway as evaluated by anesthesiologist\n* 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.'}, 'identificationModule': {'nctId': 'NCT02815150', 'briefTitle': 'Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Safety and Effectiveness of Oral Administration of 5% Glucose Solution 250ml 2-3 Hours Before Surgery in Gastric Cancer Patients for Elective Radical Resection', 'orgStudyIdInfo': {'id': '2016018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Preoperative oral carbohydrate drink: patients drink 5% glucose solution 250ml 2-3 hours before surgery.', 'interventionNames': ['Dietary Supplement: preoperative oral carbohydrate drink']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients undergo 6-8 hours of preoperative fasting.'}], 'interventions': [{'name': 'preoperative oral carbohydrate drink', 'type': 'DIETARY_SUPPLEMENT', 'description': '5% glucose solution 250ml 2-3 hours before surgery', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Dongjie Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of the Fourth Military Medical University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Dongjie Yang', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}