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ObesityJI-AI-OAGBNCT07818317

Prospective Study of an Explainable AI Tool to Support Biliopancreatic Limb Selection in One-Anastomosis Gastric Bypass

An observational study of Obesity and Severe Obesity, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This prospective observational cohort study will develop and externally validate a human-supervised, explainable artificial-intelligence decision-support model for analysing factors associated with biliopancreatic limb length selection during one-anastomosis gastric bypass (OAGB). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Severe Obesity, Metabolic Disease
What is being tested?
One-anastomosis gastric bypass with observed biliopancreatic limb length
Type of treatment
Surgery or procedure
How many people
120 participants
Where
1 siteKazakhstan
Study dates
15 Jan 2027to 1 Nov 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The proposed registration is based on the current protocol design: a prospective observational cohort for model development and external validation, nested in routine one-anastomosis gastric bypass (OAGB) care. The current protocol does not prospectively assign a biliopancreatic-limb length, does not report patient-level results, and does not claim that any BPL length is optimal. The investigators not intend to assign participants prospectively to 0.5-, 1-, 2-, or 3-m BPL groups

Who may be able to join

  • Adults aged 18 years or older at the time of consent.
  • Patients who meet the institution's independent clinical criteria for primary one-anastomosis gastric bypass.
  • Planned laparoscopic or robot-assisted OAGB at a participating centre.
  • Ability to undergo standardized intraoperative measurement of the J-I segment, P_JI components, and total small-bowel length when clinically and ethically appropriate.
  • Ability to provide informed consent according to local requirements.
  • Willingness and reasonable ability to complete the prespecified postoperative follow-up.

Who cannot join

  • Revisional, conversion, or non-primary gastric bypass surgery.
  • Operative anatomy that prevents reliable identification or measurement of the ligament of Treitz, the J-I segment, or the ileocecal junction.
  • Unaddressed altered gastrointestinal anatomy that is outside the development protocol.
  • Severe pre-existing malnutrition or another condition for which experimental variation in BPL length would be considered clinically inappropriate by the treating team.
  • Inability to provide informed consent when consent is required.
  • Inability to complete the minimum follow-up required by the approved protocol, unless the participant is retained for an approved missing-data or safety analysis.
  • Any intraoperative or postoperative circumstance in which the treating surgeon determines that protocol measurement would create unacceptable risk.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Oral Ospanov, Professor contact

87015287734

bariatric.kz@gmail.com

Kazakhstan1 site
  • Oral Ospanov

    Astana, Aqmola, 010000

    Oral Ospanov, Professor, 87015287734, bariatric.kz@gmail.com

    Oral Ospanov, 87015287734, bariatric.kz@gmail.com

Other trials in Kazakhstan

About this study

Official title: A Study Protocol for Multivariable Regression and Explainable Artificial Intelligence to Support Biliopancreatic Limb Selection in One-Anastomosis Gastric Bypass Using J-I Fat Coverage, Total Small-Bowel Length, and AII

This prospective observational cohort study will develop and externally validate a human-supervised, explainable artificial-intelligence decision-support model for analysing factors associated with biliopancreatic limb length selection during one-anastomosis gastric bypass (OAGB). The study will record three prespecified factors: the percentage of the laparoscopic instrument segment J-I covered by visceral or omental fat (P_JI = 100 × FI/JI), the measured total small-bowel length (TSBL), and the abdominal integral index (AII = (CD/AC) + (CG/EG) + (JI/FI)). The study will evaluate weight-loss effectiveness, nutritional and malabsorptive outcomes, bile/acid reflux, major complications, and technical feasibility. During model development, the AI system will not autonomously assign a BPL length. The operating bariatric surgeon will make the clinical decision, and the model will be evaluated for calibration, external validity, factor contribution, safety constraints, and abstention.

Read the detailed description

One-anastomosis gastric bypass is a metabolic-bariatric procedure in which a long gastric pouch is connected to the small bowel by a single gastrojejunostomy. The length of the biliopancreatic limb (BPL) changes the length of bowel exposed to biliopancreatic secretions before mixing with ingested nutrients and may therefore influence weight loss, metabolic response, nutritional risk, and bile/acid reflux. Existing clinical practice includes different BPL lengths, and the available evidence does not establish one universally optimal length for every patient.

This study is designed as a prospective, multicentre, observational cohort for development and external validation of an explainable clinical decision-support model. The study will enrol adults undergoing primary laparoscopic or robot-assisted OAGB as part of routine clinical care. The BPL length will not be assigned by the AI system during model development. The actual clinically selected BPL length will be recorded as an observed exposure together with operative configuration, centre, surgeon, and relevant patient characteristics.

The primary prespecified factor is P_JI, calculated as 100 × FI/JI. JI is the full measured distance from the internal left-hypochondrial trocar point J to the ligament of Treitz at point I. FI is the portion of the J-I instrument segment covered or occupied by the displaced visceral/omental fat layer. P_JI ranges from 0% to 100% and is a laparoscopic geometric coverage metric, not a direct volumetric measurement of total visceral fat.

The second factor is TSBL, measured in centimetres from the ligament of Treitz to the ileocecal junction. TSBL will be used to estimate residual absorptive bowel for each candidate BPL length. A 4-10 m interval may be used as an operational study range, but it is not a universal biological normal range; measurements outside this range will trigger quality review rather than automatic truncation.

The third factor is AII, calculated as (CD/AC) + (CG/EG) + (JI/FI). AII is a secondary geometric and technical feature. When FI equals zero, JI/FI is structurally undefined and must be handled by a prespecified missingness and sensitivity-analysis strategy rather than by substituting an arbitrary value.

The statistical baseline will be multivariable regression appropriate to each endpoint, with centre and surgeon effects handled explicitly. Nested models will compare the incremental contribution of P_JI, TSBL, and AII. Explainable AI will be used as a calibrated prediction and visualization layer, not as an autonomous decision maker. Candidate BPL actions of 0.5, 1, 2, and 3 m will be represented as research actions for analysis. Longer candidates will be subject to residual-bowel, nutritional, anatomical, uncertainty, governance, and follow-up safety constraints.

The proposed hierarchy P_JI greater than TSBL greater than AII is a falsifiable hypothesis. It may be supported, rejected, or revised after out-of-sample validation. The study will report effectiveness and harm endpoints separately and will not use an unvalidated composite outcome as the sole definition of the best BPL length. The final surgeon decision, any model override, and the reason for abstention will be documented.

Being tested
One-anastomosis gastric bypass with observed biliopancreatic limb length
Medical subject headings
Obesity, Obesity, Morbid, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • One-anastomosis gastric bypass with observed biliopancreatic limb lengthProcedure or surgery

    Participants undergo primary laparoscopic or robot-assisted one-anastomosis gastric bypass as part of routine clinical care. The observed biliopancreatic limb length, operative configuration, surgical platform, centre, and surgeon are recorded. During model development, the study does not assign a BPL length and the AI system does not replace the surgeon's clinical judgment. Candidate lengths of 0.5, 1, 2, and 3 m are research-action labels used to evaluate predictions and safety constraints, not automatically assigned treatment arms.

    Additional exposure variables:

    • P_JI (%) = 100 × FI/JI
    • TSBL in centimetres
    • AII = (CD/AC) + (CG/EG) + (JI/FI)
    • Residual absorptive bowel after observed BPL length
    • Surgical platform: laparoscopic or robot-assisted
    • Centre and surgeon identifier
    • Operative configuration and reflux-prevention technique
Study groups in NCT07818317
Study groupRoleWhat they receive
One-anastomosis gastric bypass with observed biliopancreatic limb lengthParticipants are followed from OAGB through prespecified outcomes
Receives: Procedure: One-anastomosis gastric bypass with observed biliopancreatic limb length

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent total weight loss at 12 months after OAGB

    Percent total weight loss will be calculated as 100 × (baseline body weight - body weight at 12 months) / baseline body weight. Baseline weight is measured before OAGB using the site-approved calibrated scale. The measure is continuous and will be analysed separately from nutritional harm, reflux, major complications, and technical outcomes.

    Measured: 12 months after OAGB

  2. Incremental out-of-sample predictive contribution of P_JI for 12-month percent total weight loss

    The incremental contribution of P_JI will be evaluated by comparing a prespecified baseline model without the three decision factors with a nested model adding P_JI. The analysis will report out-of-sample change in Brier score, partial R² or an endpoint-appropriate explained-variation measure, calibration, discrimination, bootstrap confidence intervals, and decision-curve net benefit. P_JI will be considered the leading factor only if its contribution is reproducibly larger than the incremental contributions of TSBL and AII under the prespecified analysis.

    Measured: From model development through external validation; primary clinical endpoint assessed at 12 months after OAGB

Secondary outcomes (8)
  1. Percent total weight loss at 24 months after OAGB

    Percent total weight loss will be calculated using baseline weight and weight at 24 months. The measure will be analysed by observed BPL length and in outcome models containing P_JI, TSBL, AII, clinical covariates, centre, surgeon, operative configuration, and candidate-length interactions when supported by the design.

    Measured: 24 months after OAGB

  2. Incremental predictive contribution of total small-bowel length

    The incremental contribution of measured TSBL will be evaluated by comparing the model containing P_JI with a nested model adding TSBL. TSBL will be analysed continuously in centimetres or after prespecified standardization. Residual absorptive bowel will be calculated for each observed BPL length. Performance will be reported with out-of-sample Brier score, calibration, discrimination, partial R² or an endpoint-appropriate explained-variation measure, and confidence intervals.

    Measured: From model development through external validation; clinical outcomes assessed at 12 and 24 months after OAGB

  3. Incremental predictive contribution of the abdominal integral index

    The incremental contribution of AII will be evaluated by comparing the model containing P_JI and TSBL with a nested model adding AII. AII will be calculated as (CD/AC) + (CG/EG) + (JI/FI). Cases in which FI equals zero will be handled as structural missingness for the JI/FI component and analysed using the prespecified missingness and sensitivity-analysis strategy.

    Measured: From model development through external validation; clinical outcomes assessed at 12 and 24 months after OAGB

  4. Nutritional and malabsorptive safety outcomes

    Nutritional and malabsorptive outcomes will be reported separately and will include protein-energy malnutrition, hypoalbuminemia, anaemia, iron or ferritin deficiency, folate deficiency, calcium or vitamin D abnormalities, vitamin B12 deficiency, fat-soluble vitamin deficiency, diarrhoea, steatorrhoea, and need for intensive or parenteral replacement therapy. Definitions, laboratory thresholds, and clinically significant-event criteria will be prespecified in the statistical analysis plan before database lock.

    Measured: Baseline, 3, 6, 12, and 24 months after OAGB, with additional clinically indicated assessments

  5. Bile and acid reflux outcomes

    Bile and acid reflux outcomes will include patient-reported reflux symptoms, need for escalation of medical therapy, endoscopic findings when clinically indicated, marginal ulcer, and revision for clinically significant reflux. The operative configuration and reflux-prevention technique will be recorded because reflux cannot be attributed to BPL length alone.

    Measured: Baseline and 3, 6, 12, and 24 months after OAGB, with event-based assessment throughout follow-up

  6. Major clinical complications and reoperation

    Major complications will include anastomotic leak, reoperation, readmission, venous thromboembolism, hospitalization, mortality, and other protocol-defined serious adverse events. Events will be adjudicated according to the approved study definitions and reported separately from weight-loss effectiveness.

    Measured: From OAGB through 24 months after surgery

  7. Technical feasibility and measurement reproducibility

    Technical outcomes will include operative time, conversion from laparoscopic or robot-assisted surgery, inability to complete the planned reconstruction, revision of the planned BPL length, intraoperative bowel injury, blood loss, instrument exchanges, and surgeon-rated workload. Measurement reproducibility will include repeated AC, CD, CG, EG, KI, JI, FI, and TSBL measurements, intraclass correlation coefficient, coefficient of variation, and frequency of measurement-related abstention.

    Measured: Intraoperative period and immediately after the operation

  8. Safety-gated candidate BPL eligibility and algorithm abstention

    For candidate BPL lengths of 0.5, 1, 2, and 3 m, the study will record whether the candidate passes prespecified residual-bowel, nutrition, anatomy, follow-up, model-applicability, and uncertainty checks. The study will report the frequency and reasons for algorithm abstention, surgeon override, and suppression of longer research-only candidates. This outcome evaluates workflow safety and does not represent proof of clinical benefit.

    Measured: At intraoperative decision-support evaluation and through 24-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start15 Jan 2027 (estimated)
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion1 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07818317
Sponsor's protocol ID
SBMS-OAGB-JIAI-001
Acronym
JI-AI-OAGB
Status last verified
Sep 2026
First submitted
7 Sep 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Severe Obesity, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oral Ospanov, Professor (87015287734, bariatric.kz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent total weight loss at 12 months after OAGB (time frame: 12 months after OAGB). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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