Total Small Bowel Length Measurement Using Computed Tomography and Magnetic Resonance Imaging in Obese Patients

NCT ID: NCT06065917

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2026-02-28

Brief Summary

The aim of the study is to set up and validate a reliable and reproducible automated method using preoperative radiological imaging to measure the TSBL in patients undergoing laparoscopic bariatric/metabolic surgery.

Detailed Description

The total length of the small intestine (TSBL) represents a crucial parameter for obtaining a safe and successful minimally invasive surgery in metabolic/bariatric bypass surgery.

Nowadays, the standard of small intestine measurement is the intraoperative measurement. Laparoscopy represents the standard approach for baratric/metabolic, making the TSBL measurement time-consuming and risky in case of intestinal lesions. An accurate and effective non-invasive preoperative measurement of the TSBL will allow to evaluate the variability of the TSBL, which affects the surgical strategy. Cross-sectional imaging could play an important role in this setting thanks to the possibility of measuring in a non-invasive way the TSBL. Some studies performed with both Computed Tomography (CT) and Magnetic Resonance (MR) report promising results. However, they are limited by the small size of the sample, the lack of standardized technique and the lack of an automatic method based on Artificial Intelligence (AI).

The evaluation of a reliable preoperative method to measure TSBL using cross-sectional imaging will potentially reduce intraoperative complications and insufficient long-term weight loss or nutritional deficiencies. In this scenario a possible solution could be the implementation of analysis method through the development of an AI algorithm capable of automatically segmenting the small intestine.

The PRIMARY END POINT of this study is to set up and validate a reliable and reproductible automatic method to measure the TSBL in patients candidates for laparoscopic bariatric/metabolic surgery, based on preoperative radiological imaging

The main phases of the project will be:

1. evaluate the feasibility of preoperative CT and MRI-base measurement of the TSBL in a large cohort of obese patients and compare radiological measurement with intraoperative laparoscopic measurement (method of elongation) as a reference standard (1).

2. Evaluate the more accurate cross-sectional imaging between CT and MRI to measure the length of the small intestine.

3. Build an AI tool that can automatically measure TSBL on transversal slice imaging.

Three high-volume Italian centers will enroll 195 obese patients who are candidates for metabolic surgery for obesity. Part of them will be established training cohort (total = 105 patients), used to set up the AI-based method of TSBL measurement. The other 90 patients (30 for each center) will represent the validation cohort.

Conditions

Obesity; Bariatric Surgery Candidate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Artificial intelligence training cohort and validation cohort

Three high-volume Italian centers will enroll 195 obese patients who are candidates for metabolic surgery for obesity. Part of them will be established a training cohort (total = 105 patients), used to set up the AI-based method of TSBL measurement. The other 90 patients (30 for each center) will represent the validation cohort.

Group Type: EXPERIMENTAL

Measurement of the total small bowel length using CT scan and MRI with 3D reconstruction and AI tool

Intervention Type: DIAGNOSTIC_TEST

The intervention consists in performing CT and MR imaging with small bowel length measurement before bariatric/metabolic surgery in obese patients. Then, during surgery the patients will undergo laparoscopic stretched small bowel measurement as the reference gold standard method to measure the small bowel length. The imaging of the training cohort will be used to trained an AI to set up an automatic method of small bowel length measurement via the analysis of CT and MRI imaging.

Interventions

Measurement of the total small bowel length using CT scan and MRI with 3D reconstruction and AI tool

The intervention consists in performing CT and MR imaging with small bowel length measurement before bariatric/metabolic surgery in obese patients. Then, during surgery the patients will undergo laparoscopic stretched small bowel measurement as the reference gold standard method to measure the small bowel length. The imaging of the training cohort will be used to trained an AI to set up an automatic method of small bowel length measurement via the analysis of CT and MRI imaging.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• BMI > 35 kg/m2 and at least one obesity-related comorbidity
• BMI > 40 kg/m2
• failure of at least six months of dietary and/or medical treatment of obesity
• indication for intervention validated after multidisciplinary evaluation in a specific board meeting

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: collaborator

Federico II University

OTHER

Sponsor Role: collaborator

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Niccolo Petrucciani

MD, PhD, Associate Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliera Universitaria Sant'Andrea

Rome, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Niccolò Petrucciani, MD

Role: CONTACT

niccolo.petrucciani@uniroma1.it

3496311476

Facility Contacts

Niccolo Petrucciani, MD

Role: primary

niccolo.petrucciani@uniroma1.it

00390633775634

Other Identifiers

C.88

Identifier Type: -

Identifier Source: org_study_id