Skip to main content

Table 1 Primary and secondary objective. Primary, secondary, and other explorative endpoints and how they are assessed

From: Monitoring of patients with microdialysis following pancreaticoduodenectomy—the MINIMUM study: study protocol for a randomized controlled trial





To evaluate if the microdialysis method will reduce the total length of stay at the hospital(s).

Number of days/hours from end of surgery to hospital discharge from primary hospital plus number of days/hours for subsequent admissions with a diagnosis associated with the primary surgery at any hospital

Hours/days from the initial operation (end of surgery) to hospital discharge. All hospitals admitting the patient are included, also transferred hospitals. From electronic patient records.

Secondary 1

To evaluate predictive score systems for POPF

Occurrence of POPF

POPF defined according to the definition of the ISGPF. Graded into “biochemical”, B or C. From medical record, CT-scans.

The following risk factors will be assessed:

Age, gender, smoking history—current and package years, preoperative BMI, weight loss, Intraabdominal fat thickness, pancreatitis history, relation to portal vein to tumor, primary diagnosis, radiological (assessed by CT-scan) PD width, intraoperative PD width, intraoperative blood loss, pancreatic texture, pancreatic fat, pancreatic fibrosis, drain amylase. From preoperative examination, medical record, CT-scan, during surgery and postoperative examinations.

Secondary 2

To evaluate if microdialysis data contribute to reduced length of stay at the primary hospital and ICU

Length of stay at the primary hospital

Length of stay at the ICU

Number of days/hours from end of initial operation to primary hospital discharge and hours admitted at the ICU. From electronic patient records.

Secondary 3

To evaluate if there is a special pattern of inflammatory markers in the microdialysate and serum in patients with/without POPF

Concentration of inflammatory markers

From laboratory analysis

Secondary 4

To evaluate the reliability and complications using microdialysis catheter CMA 65

Occurrence of catheter malfunction

Occurrence of bleedings and infections

Daily check of the microdialysis catheter is functioning.

Assessments of bleeding which affects circulatory parameter (development of circulatory shock or need of transfusion) and infection

Secondary 5

To evaluate patient quality of life and pain

Overall score and sub-scale scores of patient-reported questionnaires

Two patient-reported questionnaires:

“Abdominal surgery impact scale” will be gathered with patient-reported McGill Pain Questionnaire-2 (SF-MPQ-2) preoperatively, at POD3 ± 1 day and at discharge ± 2 days from primary hospital + 30 and 90 days after surgery.

Secondary 6

To compare hospital costs of using microdialysisis versus “standard of care”

Number of Euros per patient undergoing PD based on microdialysis costs, length of stay (ICU and inpatient stay), reoperations, and postoperative complications

From medical records, procedures noted in electronic patient records, and radiological electronic patient records.


To compare other endpoints between patient with and without a microdialysis catheter

Hours from end of surgery to diagnosis of postoperative pancreatic AL (grades B and C).

Time as noted in electronic patient records.

Total quantity (μg/mg) of vasoactive medications during surgery

Amount during surgery where the PD was performed. Derived from electronic patient records.

Fluid balance - total iv volume administered and total diuresis

Diuresis and amount of fluid given iv during surgery and postoperatively until discharge from the hospital where the PD was performed. Derived from electronic patient records.

Number of patients with biliary fistula

Biliary fistula defined according to the definition of the International Study Group of Liver Surgery (ISGLS). Graded into A, B, or C. From medical record, CT-scans.

Number of patients with gastro-enteric AL

Gastro-enteric AL. From medical record, CT-scans.

Pancreatic amylase and bilirubin concentrations in drainage fluid and in serum.

Analysis of drainage fluid and serum

White blood cell count, C-reactive protein; concentrations

Laboratory data

Number of patients with postoperative complications during total hospital stay in total and per complication

Defined by the modified Clavien-Dindo classification, from medical record, radiological examinations, and electronic patient records.

Patient’s discharge disposition

From electronic patient records.

  1. AL anastomotic leakage, BMI body mass index, CT computed tomography, ICU intensive care unit, ISGLS International Study Group of Liver Surgery, ISGPF International Study Group on Pancreatic Fistula, iv intravenous, PD pancreatoduodenectomy, POD postoperative day, POPF postoperative pancreatic fistula