Goal-directed Enteral Nutritional Perioperative Management
NCT Number: NCT06510543
Acronym: GENTLEMAN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Esophagus Cancer
Interventions: DIETARY_SUPPLEMENT: Goal-directed EN therapy|DIETARY_SUPPLEMENT: Conventional EN therapy
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-03-30
Completion Date: 2031-05-30
Locations: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China|Daping Hospital, Third Affiliated Hospital of Third Military Medical University, Chongqing, Chongqing, China|Fujian Cancer Hospital, Fuzhou, Fujian, China|Anyang Cancer Hospital, Anyang, Henan, China|First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China|Henan Cancer Hospital, Zhengzhou, Henan, China|Huai'an First People's Hospital, Huai'an, Jiangsu, China|Jiangsu Cancer Hospital, Nanjing, Jiangsu, China|Jiangsu Provincial People's Hospital, Nanjing, Jiangsu, China|Qilu Hospital of Shandong University, Jinan, Shandong, China|Shandong Provincial Hospital, Jinan, Shandong, China|Shanghai Chest Hospital, Shanghai, Shanghai, China|Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China|Changzhi People's Hospital, Changzhi, Shanxi, China|Shanxi Cancer Hospital, Chinese Academy of Medical Sciences, Taiyuan, Shanxi, China|Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China|Yunnan Cancer Hospital, Kunming, Yunnan, China

Summary:
This clinical trial aims to determine whether perioperative goal-directed nutritional therapy can prevent postoperative pulmonary and other major complications in malnourished esophageal squamous cell cancer patients. Its main question is whether individualized nutritional therapy can improve short-term surgical outcomes and long-term prognosis. Researchers will compare goal-directed and conventional nutritional therapy to identify differences in morbidities and survival.

Primary Outcome Measures: Rate of postoperative pulmonary complications, According to the Esophagectomy Complications Consensus Group (ECCG) standardization of complications reporting, pulmonary complications include pneumonia, pleural effusion, pneumothorax, atelectasis, mucous plugging, respiratory failure, acute respiratory distress syndrome, acute aspiration, tracheobronchial injury, and prolonged air-leak., Randomization to three months after surgery|Rate of unplanned hospital admissions, Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute hospital admission., Randomization to three months after surgery|Rate of unplanned ICU admission, Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute ICU admission., Randomization to three months after surgery|Overall survival, The time from randomization to death. Any patients lost to follow up or still alive at the time of evaluation are censored., Randomization to five years
Secondary Outcome Measures: Rate of postoperative non-pulmonary complications, Non-pulmonary complications according to the ECCG standardization of complications reporting., Randomization to three months after surgery|Level of serum prealbumin, Prealbumin, also known as transthyretin, has a half-life in plasma of ∼2 days, much shorter than that of albumin. Prealbumin is therefore more sensitive to changes in protein-energy status than albumin, and its concentration closely reflects recent dietary intake rather than overall nutritional status., Randomization to three months after surgery|Body mass index (BMI), A person's weight in kilograms divided by the square of height in meters., Randomization to three months after surgery|Lean body mass, The weight of the body minus the⁣ fat content, representing the amount of⁣ muscle, bone, and organs in the body., Randomization to three months after surgery|Rate of treatment-related adverse events (TRAEs), An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state., Randomization to three months after surgery|Rate of R0 resection, Distance between tumor and the circumferential resection margin (CRM) more than 1 mm., Randomization to three months after surgery|Rate of pathologic complete response (pCR), The absence of invasive/in situ cancer in the resected esophagus and regional lymph nodes., Randomization to three months after surgery|Disease-free survival (DFS), Defined as the proportion of patients without disease progression or death., Randomization to five years|Scale of health-related quality of life (HRQOL), A state of complete physical, mental and social well-being, and not merely the absence of disease and infirmity evaluated by EORTC OES18、EQ-5D、FAACT., Randomization to three months after surgery