Jejunal pouch reconstruction after total gastrectomy
Official title: Reconstruction With a Lawrence-Hunt Jejunal Pouch for Upfront Total Gastrectomy - Study Protocol of a Prospective, Single-arm, Phase II Trial
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06967571 · Data updated 2026-11-12
This study tests whether using a jejunal pouch during total gastrectomy helps reduce dumping syndrome and improve nutrition and quality of life in adults with gastric cancer or CDH1 hereditary risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | January 1, 2028 |
| Study ends | April 1, 2028 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT06967571 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with confirmed gastric tumor or CDH1 mutation and planned total gastrectomy with limited esophageal resection are eligible, provided they meet all safety criteria.
✕Probably not a fit
Patients with major comorbidities or those not meeting inclusion criteria may not benefit from this reconstruction approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines a jejunal pouch reconstruction added to total gastrectomy with Roux-en-Y esophagojejunal anastomosis. It aims to see if this modification slows gastric emptying and improves nutritional status, weight maintenance, and quality of life after surgery. Eligible patients are adults 18-75 with confirmed gastric tumors or CDH1 mutation undergoing gastrectomy and meeting safety criteria. The trial is conducted at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, with enrollment limited by specific health criteria to minimize risk. Prior data from Eastern populations suggest potential benefits, but Western-data are limited; this study seeks to validate applicability to a European patient group.
Why it matters
Potential benefit: If successful, patients could experience fewer dumping symptoms, better nutrition, and improved postoperative quality of life after total gastrectomy.
How similar studies have gone: Prior studies in East Asia have reported benefits of jejunal pouch reconstruction, and the approach has been recommended in some Western guidelines, but Western data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Annamaria Agnes, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Annamaria Agnes, MD
- Email: annamaria.agnes@policlinicogemelli.it
- Phone: +39 0630167190
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.