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Proposal and Critical Appraisal of Exclusion Criteria to the International Study Group for Pancreatic Surgery (ISGPS) Definition of Delayed Gastric Emptying
*James M Healy, *John W. Kunstman, Ronald R Salem
Yale, New Haven, CT
Objective: The International Study Group for Pancreatic Surgery (ISGPS) defined criteria to objectively standardize delayed gastric emptying (DGE) following pancreaticoduodenectomy (PD). These criteria are inclusive by design, and may overestimate actual DGE incidence. This study critically examines individual DGE cases, following PD, to determine which patients are misclassified by these criteria, and for what reasons. Exclusion criteria are proposed and evaluated, designed to focus the accepted DGE definition.
Design: Retrospective review, prospectively-collected data
Setting: Academic center
Patients: 357 consecutive patients undergoing PD by a single surgeon; 52 cases of ISGPS-defined DGE (14.6%)
Interventions: Detailed evaluation of DGE cases using accepted and novel diagnostic criteria
Main Outcome Measures: Positive predictive value of ISGPS criteria. Utility of proposed modified criteria. Genuine DGE incidence.
Results: Of 52 ISGPS-defined DGE cases, 12 (23%) appeared not to represent genuine DGE upon clinical review. Six required nasogastric tube placement for re-operation or management of emesis secondary to non-DGE conditions, 4 for re-intubation without other evidence of DGE, and 2 remained NPO to treat non-DGE conditions. The proposed exclusion criteria utilize objective radiographic data (absence of gastric distention and passage of oral contrast) and presence of documented non-DGE conditions to determine genuine DGE. The incidence of true DGE was 11.2% in this cohort. The overall positive predictive value of the ISGPS criteria was 76.9%. Pre-operative variables, DGE class, and incidence of disease-specific outcomes were similar with both definitions.
Conclusions: The ISGPS consensus guidelines promote a standardized, sensitive, and easily-applicable definition of DGE, but may falsely classify DGE in approximately 23.1%. Introduction of the proposed exclusion criteria, which establish objective radiological data as a component of the definition, could substantially limit this overestimation.
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