Status:
ACTIVE_NOT_RECRUITING
Reconstruction With a Lawrence-Hunt Jejunal Pouch After Total Gastrectomy
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Total Gastrectomy
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
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 l...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06967571
Start Date
June 1 2025
End Date
April 1 2028
Last Update
January 2 2026
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy