Gastric Cancer, Total Gastrectomy
Conditions
Keywords
gastric cancer, total gastrectomy
Brief summary
The aim of the study is to establish the efficacy of jejunal pouch reconstruction in reducing dumping syndrome in patients undergoing total gastrectomy, ultimately enhancing postoperative quality of life and nutritional status.
Detailed description
Total gastrectomy (TG) with Roux-en-Y (RY) esophageal-jejunal anastomosis is performed for various gastric malignancies or as a prophylactic strategy in patients with hereditary diffuse gastric cancer syndrome harboring CDH1 mutation at risk of developing gastric cancer. The surgical procedure is, however, complicated in the post-operative months by weight loss and nutritional deficiency in most patients, requiring frequent follow-up, and by functional issues such as reflux and dumping syndrome in about 30% of cases, which significantly impact the patient's quality of life. To prevent the poorer outcomes reported by patients undergoing total gastrectomy, one strategy could be a modification of the reconstruction method using a jejunal pouch reconstruction (JP) that may mitigate symptoms by slowing gastric emptying and enhancing nutrient absorption. JP has so far proven several benefits in improving postoperative outcomes (reflux and dumping syndrome), nutritional outcomes, and QoL up to 2 years after surgery. The technique has been mostly studied in the Eastern countries (Japan and South Korea) and, since 2021, has been recommended by the French Association of Surgery as the technique of choice for reconstruction after total gastrectomy. However, in most European centers, this technique has not yet been introduced as a routine procedure due to a relative lack of data on the clinical benefit and risk profile in the Western population.
Interventions
PROCEDUREJejunal Pouch reconstruction.
The JP will be fashioned with a standard length of 12 cm using two 60 mm staple lines, the esophago-pouch anastomosis will be performed with a circular mechanical 25 mm stapling device, and finally the staple entrance on the pouch will be closed with two layers of running sutures in Vicryl 3/0
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-75 years. * Histologically confirmed gastric tumor (including adenocarcinoma, gastrointestinal stromal tumor - GIST- or neuroendocrine tumor) or patients with CDH1 mutation, scheduled for TG with a maximal esophageal resection of \< 6 cm. * Informed consent capability.
Exclusion criteria
* Prior abdominal surgeries affecting the jejunum. * Severe comorbidities or non-appropriate organ function: uncontrolled diabetes with HbA1C \> 7.5, significant heart disease: New York Heart Association (NYHA) functional classification Class III or IV, chronic obstructive pulmonary disease (COPD) requiring oxygen supplementation or continuous positive airway pressure (CPAP), chronic corticosteroid therapy (daily for more than 6 months), neutrophil count \< 2000/mm3, hemoglobin \< 8.0 g/dL, platelet count \< 100,000/mm3, serum total bilirubin \> 1.5 mg/dL, serum aspartate aminotransferase (AST) \>100 IU/L, serum alanine aminotransferase (ALT) \>100 IU/L, and creatinine clearance (CCr) ≥ 50 mL/min), ECOG performance status \> 1. * Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dumping syndrome reduction rate | 12 months after surgery | Evaluate the reduction in the incidence of dumping syndrome after TG with JP reconstruction with the Sigstad questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dumping syndrome severity | The DSS was administered at 3, 6, and 12 months after surgery. | Dumping syndrome severity was assessed using the Arts Dumping Severity Score (DSS), an 11-item questionnaire with a total score range of 0-33, where higher scores indicate worse symptoms. |
| Nutritional status - weight | 3, 6 & 12 months after surgery | Assess the nutritional status using weight in kilograms |
| Nutritional status - height | 3, 6 & 12 months after surgery | Assess the nutritional status using height in meters |
| Nutritional status - Body Mass Index (BMI) | 3, 6 & 12 months after surgery | To Assess the nutritional status weight and height will be combined to report BMI in kg/m\^2 |
| Nutritional status | 3, 6 & 12 months after surgery | Assess the nutritional status using validated metrics such as the serum iron levels, albumin levels, B12 levels and vitamin D levels. |
| Gastrointestinal Quality of Life Index (GIQLI) | 3, 6 & 12 months after surgery | Evaluate the quality of life using using the Italian versions of the GIQLI questionnaire. The maximum GIQLI in the international score is 144 and its worst value is 0. |
| EORTC QLQ-C30 | Assessments were performed at 3, 6, and 12 months after surgery | Quality of life was assessed using the Italian version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30). All scales were transformed into scores ranging from 0 to 100. For the functional scales and the global health status/quality of life scale, higher scores indicate a better outcome, whereas for the symptom scales higher scores indicate greater symptom severity. |
| Postoperative complications | 12 months after surgery | Measure the rate of postoperative complications. All severe adverse events (SAEs) will be collected starting with the surgical admission until the end of the study period (12 months). |
Countries
Italy
Contacts
CONTACTAnnamaria Agnes, MD
PRINCIPAL_INVESTIGATORAnnamaria Agnes, MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Outcome results
None listed