Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 6:05 PM
Study NCT ID:
NCT07159659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-operative Medium Chain Triglyceride Diet May Reduce Hospital Stay Following Lung Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013899', 'term': 'Thoracic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hospital length of stay (LOS)', 'timeFrame': 'From the end of the lung resection procedure until the time of patient discharge, assessed up to 7 days post-surgery', 'description': 'hospital length of stay (LOS), which is hypothesized to be reduced following the administration of an MCT diet. Currently, patients undergoing lobectomy using VATS have a median LOS of approximately 3-4 days. The study aims to investigate whether MCT diet interventions can reduce this to 2 days, representing a 30% reduction in hospital stay.'}], 'secondaryOutcomes': [{'measure': 'Total Chest Drain Output (mL)', 'timeFrame': 'From the end of the lung resection procedure until the time of chest drain removal assessed up to 7 days post-surgery', 'description': 'Chest drain output indirectly reflects recovery status. The total chest drain output will be measured using the Medela digital chest drainage system, which is routinely used for patients undergoing lobectomy. Compared to manual drainage system, this system allows more precise monitoring of fluid output. This information will help evaluate the overall impact of the MCT diet on postoperative recovery, particularly in reducing fluid drainage.'}, {'measure': 'Patient Satisfaction and Tolerability', 'timeFrame': 'Upon discharge (assessed up to 7 days post-surgery), 2 weeks post discharge, 3 months post discharge', 'description': 'Patient-reported outcomes will be assessed using a quality of life (QoL) questionnaire, which is an established tool for evaluating recovery after surgery. The questionnaire will include:\n\n* Patient satisfaction with their recovery process\n* Tolerability of the MCT diet\n* Any challenges experienced during the diet, including adherence and acceptability'}, {'measure': 'Number of Participants with Symptoms Associated with MCT Diet', 'timeFrame': 'Upon discharge (assessed up to 7 days post-surgery), 2 weeks post discharge, 3 months post discharge', 'description': 'Patients will be monitored for any gastrointestinal discomfort associated with the MCT diet, including:\n\n* Diarrhea\n* Constipation\n* Bloating\n* Increased flatus\n\nReports of these symptoms will be collected during the hospital stay and follow-up visits to assess the safety and tolerability of the MCT diet.'}, {'measure': 'Number of patients with Infection symptoms', 'timeFrame': 'Upon discharge (assessed up to 7 days post-surgery), 2 weeks post discharge, 3 months post discharge', 'description': 'ยท Observing for symptoms such as fever or shortness of breath (SOB), which will be incorporated into the QoL questionnaire'}, {'measure': 'Number of patients with infection risk', 'timeFrame': 'Upon discharge (assessed up to 7 days post-surgery), 2 weeks post discharge, 3 months post discharge', 'description': 'Regular checks for pleural-based complications, such as effusion, through chest X-rays (performed before discharge and during follow-ups)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medium Chain Triglyceride Diet', 'Lung Resection', 'Video-assisted thoracoscopic surgery'], 'conditions': ['Thoracic Neoplasms']}, 'descriptionModule': {'briefSummary': 'Lung resection, a critical treatment for various thoracic diseases, including lung cancer, often necessitates prolonged hospitalization due to rare but severe postoperative complications such as chyle leaks, with an occurrence of 0.25%-3%, prolonging chest drainage, and delaying recovery. Therefore, effective postoperative care is essential for optimizing outcomes, reducing complications, and expediting recovery.\n\nRecent studies have highlighted the significant potential of medium-chain triglyceride (MCT) diets, owing to their unique absorption pathway and metabolic properties. MCT contains mainly medium-chain fatty acids (MCFA), which is absorbed in the intestine and transported to the liver via the portal system instead of the lymphatic system. This helps to bypass the lymphatic system, thereby reducing the volume of lymph. MCFAs also provide better energy utilization in stressed condition since it does not require carnitine shuttle upon metabolism, which is beneficial to post-operation recovery.\n\nSeveral studies have demonstrated the benefits of MCT diets in managing chyle leaks and supporting gastrointestinal recovery, particularly in conditions that strain the lymphatic system. For instance, short-term MCT-enriched diets have been associated with improved post-operation recovery of gastrointestinal, hepatic and renal functions, reduced total chest drainage volumes, and shorter hospital stay when compared to regular diet groups.\n\nPatients with post-operative chyle leak following thoracic surgery are often given an MCT diet to reduce chest drain volume and hence shorten hospital stay. Based on the successful use of MCT diet on patients with chyle leak after lobectomy, it is hypothesized that patients with chylothorax provided with post-operative MCT diet can also shorten hospital stay by decreasing chest drainage. Therefore, a prospective and randomized trial is designed to investigate how post-operative MCT diet in lung resection patients without chylothorax may affect hospital stay and post-operative recovery.', 'detailedDescription': 'This study is a single-center, prospective, randomized trial designed to investigate how a post-operative diet enriched with MCT affects recovery in patients undergoing video-assisted thoracic surgery (VATS). Medical students from the Chinese University of Hong Kong, under the supervision of the principal investigator, will conduct the study, including obtaining consent and collecting data. Experienced surgeons at the Prince of Wales Hospital will perform the VATS procedures.\n\n2.2 Hypotheses\n\n1. MCT diet can speed up post-operative recovery and shorten hospital length of stay.\n2. MCT diet poses no adverse effects in post-operative recovery for patients without chyle leak following lung surgery.\n3. The use of MCT diet after discharge for 2 weeks can enhance patient recovery and possibly reduce readmissions or complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral Inclusion Criteria for All procedures:\n\n1. Age between 18 - 80 years\n2. Body mass index \\<35 kg/m2\n3. Suitable for minimally invasive surgery\n4. Willingness to participate as demonstrated by giving informed consent\n\nProject-specific Criteria:\n\n1\\. Patients performed lobectomy with lymph node dissection\n\nExclusion Criteria:\n\nPatient general exclusion criteria:\n\n1. Contraindication to general anesthesia\n2. Severe concomitant illness that drastically shortens life expectancy or increases the risk of therapeutic intervention\n3. Untreated active infection\n4. Non-correctable coagulopathy\n5. Emergency surgery\n6. Vulnerable population (e.g. mentally disabled, pregnancy)\n\nProject-specific Criteria\n\n1. Segmentectomy\n2. Pleurodesis\n3. Esophageal procedures\n4. Redo/readmitted patients for lung resection\n5. Chylothorax (Triglyceride \\> 110 mL, excluded at day 1 routine lab check)\n6. Air leak (\\> 30 mL/min when back to ward)\n7. Heart Failure\n8. Renal failure (estimated GFR \\< 30; CKD grading stage 4-5)\n9. Moderate to severe adhesion (defined at randomization by surgeon; criteria include estimated surface area of adhesion and staging)\n10. History of tuberculosis or empyema'}, 'identificationModule': {'nctId': 'NCT07159659', 'briefTitle': 'Post-operative Medium Chain Triglyceride Diet May Reduce Hospital Stay Following Lung Resection', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Post-operative Medium Chain Triglyceride Diet May Reduce Hospital Stay Following Lung Resection', 'orgStudyIdInfo': {'id': 'MCT Study Protocol version 1.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients in the control group will receive a standard hospital diet consistent with routine postoperative nutritional care after lobectomy with lymph node dissection. This diet does not include medium-chain triglyceride (MCT) supplementation and serves as a comparator to evaluate the effects of the MCT diet on postoperative recovery'}, {'type': 'EXPERIMENTAL', 'label': 'MCT diet during hospital stay', 'description': 'Patients will receive a medium-chain triglyceride (MCT)-enriched diet during their hospital stay following lobectomy with lymph node dissection. The MCT diet is administered as part of the postoperative nutritional regimen to evaluate its impact on recovery outcomes', 'interventionNames': ['Dietary Supplement: MCT Diet']}, {'type': 'EXPERIMENTAL', 'label': 'MCT diet during hospital stay and 2 weeks after discharge', 'description': 'Participants will receive a medium-chain triglyceride (MCT) diet during their hospital stay and for two weeks following discharge. This aims to evaluate the effects of continued MCT dietary supplementation on postoperative recovery outcomes after lobectomy with lymph node dissection', 'interventionNames': ['Dietary Supplement: MCT Diet']}], 'interventions': [{'name': 'MCT Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'MCT diet for patients following lung resection', 'armGroupLabels': ['MCT diet during hospital stay', 'MCT diet during hospital stay and 2 weeks after discharge']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'country': 'Hong Kong', 'contacts': [{'name': 'Calvin Sze Hang Ng', 'role': 'CONTACT', 'email': 'calvinng@surgery.cuhk.edu.hk', 'phone': '+852 3505 2618'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Calvin Sze Hang Ng', 'role': 'CONTACT', 'email': 'calvinng@surgery.cuhk.edu.hk', 'phone': '+852 3505 2618'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Calvin Sze Hang Ng', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}