NCT06967571

Reconstruction With a Lawrence-Hunt Jejunal Pouch After Total Gastrectomy

Reconstruction With a Lawrence-Hunt Jejunal Pouch for Upfront Total Gastrectomy - Study Protocol of a Prospective, Single-arm, Phase II Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Gastrectomy
• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Jejunal 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

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-01-01
• Completion: 2028-04-01
• First posted: 2025-05-13
• Last updated: 2026-01-02

Locations

1 site across 1 country: Italy