Reconstruction With a Lawrence-Hunt Jejunal Pouch After Total Gastrectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Jejunal Pouch reconstruction.
Procedure/SurgeryThe 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
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: Open or laparoscopic TG followed by JP reconstruction.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dumping syndrome reduction rate
Evaluate the reduction in the incidence of dumping syndrome after TG with JP reconstruction with the Sigstad questionnaire.
Time frame
12 months after surgerySecondary outcomes
1
Dumping syndrome severity
Dumping syndrome severity was assessed using the Arts Dumping Severity Score (DSS), an 11-item questionnaire with a total score range of 0-33, where higher scores indicate worse symptoms.
Time frame
The DSS was administered at 3, 6, and 12 months after surgery.2
Nutritional status - weight
Assess the nutritional status using weight in kilograms
Time frame
3, 6 & 12 months after surgery3
Nutritional status - height
Assess the nutritional status using height in meters
Time frame
3, 6 & 12 months after surgery4
Nutritional status - Body Mass Index (BMI)
To Assess the nutritional status weight and height will be combined to report BMI in kg/m\^2
Time frame
3, 6 & 12 months after surgerySponsors and contacts
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Source ClinicalTrials.gov