Reconstruction With a Lawrence-Hunt Jejunal Pouch After Total Gastrectomy

Not Applicable

Not yet recruiting

• Conditions: Total Gastrectomy; Gastric Cancer

• Registration Number: NCT06967571
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Study Start: 2025-06-01
• Primary Completion: 2028-01-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Dumping syndrome severity	3, 6 & 12 months after surgery	Assess the severity of dumping syndrome with the Arts Dumping Severity Score (DSS) questionnaire
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	3, 6 & 12 months after surgery	Evaluate the quality of life using using the Italian versions of the EORTC QLQ-C30 questionnaire. The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.
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).

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy