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Search / Trial NCT06967571

Reconstruction With a Lawrence-Hunt Jejunal Pouch After Total Gastrectomy

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · May 12, 2025

Trial Information

Current as of September 09, 2025

Not yet recruiting

Keywords

Gastric Cancer Total Gastrectomy

ClinConnect Summary

This clinical trial is studying a surgical procedure called jejunal pouch reconstruction for patients who have undergone a total gastrectomy, which is the complete removal of the stomach, often due to gastric cancer. The main goal of the trial is to see if this reconstruction can help reduce a condition known as dumping syndrome—a problem that can occur after stomach surgery, leading to discomfort and nutritional issues. By improving these symptoms, the researchers hope to enhance the quality of life and nutritional status for patients after their surgery.

To participate in this study, individuals must be adults aged 18-75 who have been diagnosed with certain types of stomach tumors or have a specific genetic mutation linked to gastric cancer. They should also be scheduled for surgery that involves removing part of the esophagus. However, people with certain health issues, previous surgeries that affect the intestines, or those who are pregnant or breastfeeding will not be eligible to join. This trial is not yet recruiting participants, but once it starts, those who qualify can expect careful monitoring and support throughout their involvement.

Gender

ALL

Eligibility 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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Annamaria Agnes, MD

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported