LiverGroup.org. Case Report Form (CRF) for STAGED procedures

Transcription

1 Case Report Form (CRF) for STAGED procedures Patient Characteristics Case number * Age * ( 18)y Gender * Male Female Race * Caucasian Asian African Other If other race, please specify Height * cm Weight * kg Disease Characteristics Comorbidities * ne Coronary Artery Disease. Heart Failure Diabetes Mellitus Metastatic Ca. Hepatitis B or C Cirrhosis Stroke COPD/Asthma Other Reason for liver resection * Benign liver disease. Malignancy Other If other reason, please specify Tumor type * Cholangiocarcinoma hilar Cholangiocarcinoma intrahepatic Colorectal liver metastases Focal nodular hyperplasia. Hemangioma Hepatic adenoma Hepatoblastoma Hepatocellular carcinoma dular regenerative hyperplasia n-colorectal liver metastases Sarcoma Other If non-colorectal liver metastasis, specify If hilar cholangiocarcinoma, indicate Bismuth type I II IIIa IIIb IV Preoperative biliary drainage Endoscopic biliary drainage Endonasal biliary drainage Percutaneous transhepatic biliary drainage If preoperative biliary drainage, indicate side Left Right Both left and right Preoperative cholangitis Disease Characteristics continued If colorectal cancer, indicate mutation(s) ne KRAS BRAF CDX2 Unknown Total number of tumors # Diameter of the largest tumor mm Sequence Synchronous Primary first Liver first Combined Metachronous TNM classification of the primary Tx Tis T1 T2 T3 T4a T4b N0 N1 N2, M0 M1a M1b CEA in serum prior to liver resection ng/ml Chemotherapy prior to Stage 1 * If chemotherapy, which agent? FOLFOX FOLFIRI Other Number of cycles. Biological agent used * If biological, which agent? Cetuximab Bevacizumab Other Previous abdominal surgery prior to Stage 1*. Previous liver resection prior to Stage 1 * Liver parenchyma* Unknown rmal Fibrosis Cirrhosis Steatosis Chemo Dialysis prior to stage 1* Laboratory values prior to stage 1 INR prior to Stage 1 ratio Bilirubin prior to Stage 1 µmol/l The reference range of total bilirubin is typically Creatinine prior to Stage 1 µmol/l ICG plasma disappearance rate % IGC retention at 15 min % To convert lab values from mg/dl to μmol/l use our online converter:

2 Liver volume and function prior to stage 1 Total liver volume (volumetry) cc FLR (voluemtry) cc sflr ratio Use our online sflr calculator to calculate the statdardised FLR: HIDA FLR liver segments (multiple options) HIDA Amsterdam index of FLR prior to Stage 1 %/min/m2 Bilirubin at time of HIDA scan prior to Stage 1 µmol/l The reference range of total bilirubin is typically 2-20 µmol/l. Stage 1 Procedure Characteristics Intended approach for the two stage procedure * Two stage hepatectomy with PVL Two stage hepatectomy with PVE Classic ALPPS Hybrid ALPPS Tourniquet ALPPS Partial ALPPS Mini ALPPS Other Operation duration for Stage 1 min Mode of operation * Open Laparoscopic Robotic Hybrid If hybrid, please explain: Procedure characteristics for stage 1 Procedure performed * Please describe the procedure performed above. Example stage 1 classic ALPPS with right trisectionectomy plane and wedge resection segment 2, T-tube insertion. Exploration without resection * Stage 1 Procedure Segments ne Wedge Resection Ablation If wedge resections for Stage 1, number Procedure characteristics continued If ablation, device used for stage 1 Radiofrequency (RFA) Ethanol Microwave Cryotherapy Nanoknife Other Complexity features for stage 1 (multiple allowed) ne hilar lymphadenectomy more than 1 liver resection resection and ablation portal vein resection and reconstruction hepatic vein resection and reconstruction hepatic artery resection and reconstruction vena cava resection and reconstruction bile duct resection and extrahepatic reconstruction bile duct resection and intrahepatic reconstruction associated enteric resection and reconstruction extrahepatic non-gastrointestinal resection ante situ perfusion and resection ex situ perfusion and resection If vena cava reconstruction, indicate material Autologous Prosthetic Biological Exposure for Stage 1 * (multiple allowed) t applicable (like in wedge or ex situ) Right lobe mobilization Hanging maneuver Anterior approach Laparoscopic Robotic Vascular exclusion for Stage 1 (multiple allowed) ne On-demand Pringle Intermittent Pringle Pringle + vena cava inferior clamping. Total vascular exclusion Total clamp time min Transection for Stage 1 * (multiple allowed) Transection for Stage 1 Crush clamp CUSA Bipolar Stapler ne Other Transection time min Intraoperative and first 24h after Stage 1 postop blood transfusions * units Extubated in the operation room*

3 Portal vein embolisation (PVE) after Stage 1 PVE after stage 1* Days from stage until PVE days Postoperative Laboratory Values after Stage 1 Bilirubin 5 days after stage 1 µmol/l Peak bilirubin after stage 1 µmol/l The reference range of total bilirubin is typically 2-20 INR 5 days after stage 1 ratio Creatinine 48 hours after Stage 1 µmol/l Maximum lactate levels afer stage 1 μmol/l rmal range values for venous lactate are Dialysis/CVVH 5 day after stage 1. In-Hospital Complications after Stage 1 Clavien-Dindo Classification until stage 2. Please indicate the grade and number of complications for each grade below: Grade I number of complications * # Grade II number of complications * # Grade IIIa number of complications * # Grade IIIb number of complications * # Grade IVa number of complications * # Grade IVb number of complications * # Grade V - Death * Alive Dead FABIB Classification after stage 1* Failure Ascites Bile leak Infection ne A B C Bleeding Hospitalisation for stage 1 alone Discharged home between the two Stages? ICU stay for stage 1 * days Hospital stay for stage 1 alone * days Death (90 day) after stage 1 * 90 day follow up not yet completed. Unknown If death, cause of death Readmission (90 day) * 90 day follow up not yet completed Unknown Stage 2 Procedure Stage 2 Procedure Characteristics Was a planned Stage 2 Procedure performed? * Days from Stage 1 to Stage 2 days Operation duration for Stage 2 min Mode of resection for Stage 2 Open Laparoscopic Robotic Hybrid If hybrid for Stage 2, please explain Laboratory Values prior to Stage 2 INR prior to Stage 2 ratio Bilirubin prior to Stage 2 µmol/l The reference range of total bilirubin is typically Creatinine prior to Stage 2 µmol/l ICG plasma disappearance rate % IGC retention at 15 min % To convert lab values from mg/dl to μmol/l use our online converter: Liver volume and function prior to stage 2 Total liver volume (volumetry) cc FLR (voluemtry) cc sflr ratio Days from pre-stage 1 to pre-stage 2 volumetry imaging days HIDA FLR liver segments (multiple options) HIDA Amsterdam index of FLR prior to Stage 2 %/min/m2 Bilirubin at time of HIDA scan prior to Stage 2 µmol/l Procedure characteristics for stage 2 Exploration without resection * Procedure performed * Stage 2 Procedure Segments ne Wedge Resection Ablation

4 Procedure characteristics for stage continued If wedge resections for Stage 2, number If ablation, indicate the device used Radiofrequency (RFA) Ethanol Microwave Cryotherapy Nanoknife Other Complexity features for stage 2 (multiple allowed) ne hilar lymphadenectomy more than 1 liver resection resection and ablation portal vein resection and reconstruction hepatic vein resection and reconstruction hepatic artery resection and reconstruction vena cava resection and reconstruction bile duct resection and extrahepatic reconstruction bile duct resection and intrahepatic reconstruction associated enteric resection and reconstruction extrahepatic non-gastrointestinal resection ante situ perfusion and resection ex situ perfusion and resection (indicate below) If vena cava reconstruction, indicate material Autologous Prosthetic Biological Exposure for stage 2 (multiple allowed) t applicable (like in wedge or ex situ) Right lobe mobilization Hanging maneuver Anterior approach Laparoscopic Robotic Vascular exclusion for stage 2 (multiple allowed) ne On-demand Pringle Intermittent Pringle Pringle + vena cava inferior clamping Total vascular exclusion Total clamp time min Transection for stage 2 (multiple allowed) Transection for stage 2 Clamp crush CUSA Bipolar Stapler ne Other Transection time for stage 2 min Intraoperative and first 24h Stage 2 postop blood transfusions units Extubated in the operation room Postoperative Laboratory Values after Stage 2 Bilirubin 5 days after stage 2 µmol/l Peak bilirubin after stage 2 µmol/l The reference range of total bilirubin is typically 2-20 INR 5 days after stage 2 ratio Creatinine 48 hours after Stage 2 µmol/l Maximum lactate levels after stage 2 μmol/l rmal range values for venous lactate are Dialysis/CVVH 5 after stage 2. Complications after Stage 2 Clavien-Dindo Classification from stage 2 and up to 90 days from stage 1. Please indicate the grade and number of complications for each grade below: Grade I number of complications # Grade II number of complications # Grade IIIa number of complications # Grade IIIb number of complications # Grade IVa number of complications # Grade IVb number of complications # Grade V - Death Alive Dead FABIB Classification after stage 2 Failure Ascites Bile leak Infection ne A B C Bleeding Hospitalisation for stage 2 alone ICU stay for stage 2 days Hospital stay for stage 2 days Death after stage 2 up to 90 days after stage 1 90 day follow up not yet completed. Unknown If dead, cause of death Readmission after stage 2 up to 90 days after stage 1 90 day follow up not yet completed Unknown

5 Completion of data for both stages Please confirm below whether all data until hospital discharge and/or the 90 day follow up from stage 1 up are completed. All data until discharge from hospital are completed * All data until the 90th postoperative day after stage 1 are completed * Instructions Mandatory fields: All field names followed by an asterisk (*) are mandatory for case submission. Case Number: Please add the unique case number as an identifier. Do not use the hospital number or patient identifiers. Please keep a separate list of anonymized case numbers linking to the patient hospital number somewhere safe at your institution. This will help you identify patients in the CRF for further editing if needed. Calculators: The LiverGroup.org platform has integrated calculators for your convenience and to ensure uniform data collection. You may find Laboratory Unit Converters and the sflr Calculator. Terminology: The LiverGroup.org platform has further information regarding the following classifications: Brisbane, Clavien-Dindo, FABIB, BCLC Staging and the Bismuth-Corlette classifications. Comments (optional)