The recent SAGES guideline on intraoperative imaging of the common bile duct (CBD) has generated considerable discussion within the surgical community, particularly regarding its conditional recommendations on routine intraoperative cholangiography (IOC). In this commentary, we write to clarify what they mean, how they were derived, and how they should be applied in clinical practice.
Related SAGES Publications
For the full guideline recommendations and supporting evidence review, please reference the following related SAGES publications:
- Guidelines for the Use of Intraoperative Imaging of the Common Bile Duct
- Intraoperative Imaging of the Common Bile Duct: A Systematic Review
Evidence-Based Guidelines Reflect the Evidence That Exists
Clinical practice guidelines are a synthesis of the best available evidence at a given point in time, appraised through a rigorous and transparent process. The SAGES guideline was developed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) and EtD (Evidence to Decision) frameworks, which are widely recognized as the international standards for guideline development. GRADE requires that every recommendation be grounded in a systematic review of the literature and that the strength of each recommendation explicitly reflects the certainty of the underlying evidence. In other words, it provides the framework for “grading” the evidence and providing an overall certainty of the evidence available. In this guideline outcomes of interest can be found in a separately published systematic review and meta-analysis.
The EtD framework provides a transparent and organized method to go from the graded evidence to a decision by the panel. Considerations including the harms, benefits, balance of each of these, certainty of evidence, values, acceptability and feasibility are all reviewed and voted on by panelists. This framework also provides the scaffold for robust discussion and discourse between panelists to come to a decision. e This guideline, therefore, does not reflect the opinion of a panel of experts who favor one approach over another; rather, it reflects what the current body of evidence, when rigorously appraised, supports. We recognize that panelists can be biased for various reasons, including their personal experience, which is why a diverse panel with several members is necessary to ensure a balanced discussion and decision is made.
What “Conditional” Actually Means
Perhaps the most important concept to understand is the meaning of a conditional recommendation. Under GRADE, recommendations are either strong or conditional. A strong recommendation means that the evidence is sufficiently robust and consistent that the panel is confident the benefits outweigh the harms for virtually all patients in virtually all settings. A conditional recommendation means the benefits probably outweigh the harms, but with enough uncertainty, due to limited evidence quality, variability in patient circumstances, or a close balance of effects, that the right choice may differ depending on the individual patient and clinical context (Table 1).
The available evidence demonstrated a clear directional effect, which supported issuing a recommendation. However, that recommendation is conditional rather than strong for three specific reasons: 1. the available evidence is predominantly observational and rated as low or very low certainty; 2. bile duct injury, the most critical outcome, is rare enough that even large studies lack the power to detect reliable differences between techniques; and 3. There is meaningful variability in how patients value outcomes and variability in the institutional resources (C-arm availability, fluoroscopy licensing, trained personnel) required to implement routine IOC. Where these factors create uncertainty, GRADE methodology appropriately designates a recommendation as conditional. The GRADE working group is explicit on this point: conditional recommendations always warrant a shared decision-making approach, and clinicians may reasonably choose differently based on individual context.
Clinical Autonomy Is Preserved and Expected
Conditional recommendations by design preserve clinical autonomy. The guideline explicitly notes that in patients with normal laboratory values, a definitive critical view of safety, and no other specific indication, the recommendation to perform routine IOC “could be considered on an individual basis, taking into account surgeon experience, patient-specific factors, and institutional resources.” Resource constraints, fluoroscopy licensing requirements, C-arm availability, and case complexity are all acknowledged as legitimate factors shaping implementation. This is an intentional feature of conditional recommendations under GRADE.
The guideline also reinforces the importance of training residents in IOC performance and interpretation, and emphasizes maintaining proficiency among practicing surgeons.
Conclusion
This guideline represents a rigorous and transparent appraisal of the available evidence governing intraoperative imaging during laparoscopic cholecystectomy. The conditional designation of its recommendations reflects the current state of the literature, not a lack of clinical direction. The panel made recommendations where the evidence provided guidance and was explicit about the uncertainties that preclude stronger ones. Constructive engagement with these recommendations should therefore focus not on challenging the conclusions, but on addressing the evidentiary gaps that informed them. Adequately powered, prospective, multicenter studies comparing intraoperative imaging strategies remain the most important next step in this field. Until such evidence emerges, these guidelines offer surgeons a transparent, evidence-informed framework within which clinical judgment, patient-specific factors, and institutional context should guide decision-making (Table 2), which is precisely the purpose a conditional recommendation is designed to serve.
Table 1. GRADE Certainty of the Evidence and Its Interpretation
| Certainty Level | Interpretation |
| High | The authors have high confidence that the true effect is close to the estimated effect. |
| Moderate | The authors believe that the true effect is likely to be close to the estimated effect. |
| Low | The true effect may be substantially different from the estimated effect. |
| Very Low | The true effect is likely to be substantially different from the estimated effect. |
Available at: https://gdt.gradepro.org/app/handbook/handbook.html
Table 2. Implications of the Strength of Recommendations According to Different Guideline Users
| Strength of the Recommendation | Strong | Conditional |
| Clinicians | Most individuals should receive the recommended course of action. Adherence to this recommendation could be used as a quality criterion or performance indicator. Formal decision aids are not likely to be needed to help individuals make decisions aligned with their values and preferences. | Different choices may be appropriate for different patients, and clinicians must assist each patient in making a management decision consistent with their values and preferences. Decision aids may be useful to help individuals make choices aligned with their values and preferences. Clinicians should expect to spend more time in shared decision-making. |
| Patients | Most people in this situation would want the recommended course of action, and only a small proportion would not. | While many would prefer the suggested course of action, a substantial number would not. |
| Policymakers / Health System Decision-Makers | The recommendation can be adopted as policy in most situations, including as a basis for performance indicators. | Policymaking will require extensive deliberation and stakeholder engagement. Policies are more likely to vary across regions. Performance indicators should reflect the need for proper deliberation on available management options. |
Available at: https://gdt.gradepro.org/app/handbook/handbook.html
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Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.
Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.