Table 2 Assessment Schedule

Eligibility screen

≥ 1 day prior surgery

Information - signed informed consent

≥ 1 day prior surgery

Inclusion

X

Randomization

X

Intervention - microdialysis

X

X

Control (standard care)

X

X

Start eCRF

X

Premedication

X

Epidural

X

Arterial catheter

X

Central venous line

X

Targeting anesthesia

SpO₂ ≥ 93%. BPmap ≥ 60 mmHg. Body temperature ≥ 36 °C. Ventilatation with 6–8 ml/kg PBW

Pantoperazole 40 mg iv

Administered daily for 7 days

 Patient characteristics

Gender, age, height, weight, BMI, blood pressure, heart rate, SpO2

SOFA-score

X

Daily until POD 10 if applicable

Weight loss last 6 months

X

Concomitant medication

X

Smoking history

Current, pack years

Medical history

Including pancreatitis

Preoperative chemotherapy

X

Preoperative CT scan

X

 Intraabdominal fat thickness

X

 The relation to portal vein to tumor

X

 Width of pancreatic duct

X

 Width of pancreas

X

 Current diseases

Histology – differentiation of tumors and TNM staging

X

Quality of life questionnaire - Abdominal surgery Impact scale

> 1 day before surgery. After inclusion but before randomization

POD 3

X

X

X

Short-form McGill Pain Questionnaire-2 (SF-MPQ-2)

> 1 days before surgery. After inclusion but before randomization

POD 3

X

X

X

Blood samples

Hb, Trc, WBC, ASAT, ALAT, GGT, ALP, LD, Amylase, Bilirubin, Creatinine, Urea, GFR, CRP, a panel of inflammatory markers, s-lactate, and arterial blood gas.

Daily at 08.00 am: Hb, Trc, WBC, Amylase, ASAT, ALAT, GGT, LD, ALP, Bilirubin, Creatinine, GFR, UREA, CRP, a panel of inflammatory markers, s-lactate, arterial blood gas.

iv fluid

X

Urine output

X

Blood loss

X

Transfusion

X

X

Use of vasoactive medicaments

X

Intraoperative PD width

X

Intraoperative pancreatic consistency

X

 Pancreatic fat

X

 Pancreatic fibrosis

X

Drain tube

Insertion

Cessation POD 1–3 (or more) unless the effluent is bile, enteric stained or turbid or depending on microdialysis concentrations

 Amylase and bilirubin in drain fluid

At POD 1–3 and on indication thereafter if drain still in place

Pantoperazole 40 mg iv

Administered daily for 7 days

Sampling/analyzing microdialysate

Every hour in the first 24 h. Thereafter, every two hours until POD 2. From POD 2: every 4th hour until discharge; Pyruvate, lactate, glucose, glycerol

 Collecting microdialysate for cytokines

Twice daily (≈ 08.00 am and 08.00 pm)

 Microdialysis catheter function and duration

X

X

Abdominal CT scan during admission(s)

POD 2 in patient with high microdialysate concentrations in three consecutive microdialysate samples and/or at the surgeon's discretion

at the surgeons discretion

at the surgeons discretion

at the surgeons discretion

Postoperative complications - Clavien-Dindo classification ≥ 2

X

X

X

X

Time from end of surgery to a diagnosed anastomosis leakage, if applicable

X

X

X

X

Type of complications

X

X

X

X

Type of procedures due to complications

X

X

X

X

Cost of complications

X

X

X

X

Transfer(s) to ICU

X

X

X

X

LOS at primary hospital and ICU

X

X

X

X

LOS at secondary hospital

X

X

Mortality

X

X

X

X

X