Twenty Years of Pancreatic Surgery in Iceland: a Retrospective Cohort Study
Conditions: Pancreatectomy, Pancreatoduodenectomy, Distal Pancreatectomy (DP)
Sponsor: Linkoeping University

Study protocol Pancreatic surgery in Iceland, 2023-07-16 
Study protocol 
Twenty years of pancreatic surgery in Iceland: a retrospective cohort study 
 
Background: 
Pancreatic surgery is often occasioned by cancer in the pancreas or periampullary region, 
where pancreatic ductal adenocarcinoma (PDAC) is the most common diagnosis. This disease 
has a dire prognosis and is projected to soon surpass breast cancer as the third leading cause 
of cancer death in the European Union. The overall 5-year survival rate is reported to be 10% 
in the US, to a large extent due to the fact that 80-85% of patients are inoperable at diagnosis.1 
Survival after resection is better but not high, reported to be between 20 and 25% 5 years after 
surgery.1, 2  Periampullary tumors – including ampullary, duodenal and distal bile duct 
carcinomas – have a better survival with a postoperative 5-year survival rate of around 45%.2 
Apart from these diagnoses, pancreatic surgery is occasionally performed due to 
neuroendocrine tumors, chronic pancreatitis, metastases from renal cancer, and, increasingly, 
for premalignant cystic lesions such as intraductal papillary mucinous neoplasms (IPMN).3, 4  
 
Pancreatic operations are large and complex procedures, with reported rates of severe 
complications (Clavien-Dindo ≥3a) after pancreaticoduodenectomy (PD) between 20 and 
30% in modern data, and up to 38% after total pancreatectomy.5, 6 Distal pancreatectomy (DP) 
is a smaller procedure where the most usual postoperative complication is leakage of 
pancreatic fluid from the divided pancreas.7 Minimally invasive pancreatic surgery has come 
the furthest among distal resections, where three randomized controlled trials have now 
shown the safety of the technique both from a perioperative and an oncological perspective.7-9 
Recent international guidelines recommend minimally invasive distal pancreatectomy (MIDP) 
to be considered for benign, pre-malignant and malignant lesions alike in the pancreatic body 
or tail.10   
 
The question of volume in pancreatic surgery has been a growing topic over the last decade, 
with many studies indicating an advantage in terms of rate of resections, rate of radical 
resections, short-term and overall mortality with increasing hospital volume.11-13 Current 
international recommendations for training in minimally invasive pancreatic resections 
recommend an annual hospital volume of 50 PDs and 10 DPs to qualify for a training 
program.14 
 
Iceland is a small country in a unique situation, with a population of 380 000 people and 
situated on the border of the North Atlantic and Arctic oceans.15 There is one university 
hospital in the capital of Reykjavik, performing the majority of the surgery and all of the 
malignancy surgery on the island. As this is by necessity a low-volume hospital in terms of 
pancreatic surgery, there is a long tradition of specialists training overseas to gain sufficient 
experience and volumes to be able to maintain a good standard of care despite the isolated 

Study protocol Pancreatic surgery in Iceland, 2023-07-16 
conditions of the island. There is, however, limited information available on the outcomes of 
pancreatic surgery in the country. 
 
The aim of this study is to investigate the outcomes of pancreatic surgery in Iceland over the 
last 20 years. 
 
Study characteristics: 
This is a retrospective cohort study with data accessed from patients’ medical journals. 
 
Patients:  
All patients who have undergone pancreatic resection in Iceland between 2002-2022 will be 
included in the study. For the secondary outcome of duodenal cancer, patients with duodenal 
cancer who did not undergo resection in the same time span will also be included. 
 
Primary outcome:  
The primary outcome of the study is the rate of severe complications and short-term mortality 
after pancreatic resections in Iceland. 
 
Secondary outcomes: 
- 
Demographic, operative and postoperative data after pancreatic resections compared 
between operation methods. 
- 
Oncological data and survival among patients with pancreatic and periampullary 
cancer.  
- 
Outcomes after pancreatic surgery among patients who underwent resection for cystic 
lesions. 
- 
Comparison of patients who underwent minimally invasive distal pancreatectomy 
during the study period to those who underwent open distal resection. 
- 
Demographic and histopathological data as well as survival compared between 
patients with duodenal cancer who underwent resection and patients who did not. 
- 
Trends over time in the usage of pancreatic and minimally invasive surgery as well as 
changes in outcomes. 
 
 
 
 
 

Study protocol Pancreatic surgery in Iceland, 2023-07-16 
Variables accessed from the medical journals of patients: 
Preoperative data 
Operative data 
Postoperative data 
Histopathological data 
and survival 
Age 
Operation date 
Clavien-Dindo 
complication score16 
TNM stage 
Gender 
Operation time 
Postoperative 
pancreatic fistula17 
Radicality 
Body mass index 
Type of operation 
Delayed gastric 
emptying18 
Lymph nodes acquired 
and positive 
Comorbidities 
Minimally invasive 
or open 
Postpancreatectomy 
hemorrhage 19 
Histopathological 
diagnosis 
Preoperative medicines 
including statins 
Type of pancreatic 
anastomosis 
Bile leak20 
Oncologic treatment 
including details 
ASA score 
Blood loss 
Postpancreatectomy 
acute pancreatitis21 
Date of recurrence 
ECOG performance status Arterial or venous 
resection 
Blood and drain 
amylase and bilirubin 
levels 
Date of death 
Unintended weight loss 
Additional organ 
resection 
Days with drain 
 
Smoking 
Splenectomy 
Radiologic drain 
placement 
 
Date of diagnosis 
 
Intensive care and 
days 
 
Date of treatment decision  
Reoperation and 
details 
 
Date of multidisciplinary 
conference 
 
Wound dehiscence 
 
Preoperative biliary 
drainage 
 
Wound infection 
 
Preoperative endoscopic 
ultrasound 
 
Pneumonia 
 
Other preoperative 
intervention 
 
Cardiovascular 
complications 
 
Preoperative blood tests: 
CEA, Ca 19-9, 
hemoglobin, bilirubin, 
albumin 
 
Neurological 
complications 
 
Preoperative cyst fluid 
tests 
 
Thromboembolism 
 
Preoperative biopsy 
 
Length of hospital stay 
 
Preoperative TNM stage 
 
In-hospital mortality 
 
Preoperative assessment 
(resectable, borderline, 
locally advanced or 
metastasized) 
 
Textbook outcome22 
 
Neoadjuvant 
chemotherapy including 
details 
 
 
 
ASA, American Society of Anesthesiologists; ECOG, Eastern Cooperative Oncology Group; 
TNM, tumor, node, metastasis. 

Study protocol Pancreatic surgery in Iceland, 2023-07-16 
 
Time frame: 
- 
Developing study protocol and seeking ethical permission: summer of 2023. 
- 
Data collection: autumn of 2023 to spring of 2024. 
- 
Data analyses and writing of manuscript: rest of 2024. 
- 
Publication: 2025. 
 
References:  
1. 
Mizrahi JD, Surana R, Valle JW, Shroff RT. Pancreatic cancer. Lancet. 
2020;395(10242):2008-20. 
2. 
RCC. Pancreatic Cancer: National Practice Guidelines (in Swedish). Regionala 
cancercentrum i samverkan. 2021. 
3. 
Tanaka M, Fernández-Del Castillo C, Kamisawa T, Jang JY, Levy P, Ohtsuka T, 
et al. Revisions of international consensus Fukuoka guidelines for the management of IPMN 
of the pancreas. Pancreatology. 2017;17(5):738-53. 
4. 
European evidence-based guidelines on pancreatic cystic neoplasms. Gut. 
2018;67(5):789-804. 
5. 
Gleeson EM, Pitt HA, Mackay TM, Wellner UF, Williamsson C, Busch OR, et 
al. Failure to Rescue After Pancreatoduodenectomy: A Transatlantic Analysis. Ann Surg. 
2021;274(3):459-66. 
6. 
Latenstein AEJ, Mackay TM, Beane JD, Busch OR, van Dieren S, Gleeson EM, 
et al. The use and clinical outcome of total pancreatectomy in the United States, Germany, the 
Netherlands, and Sweden. Surgery. 2021;170(2):563-70. 
7. 
de Rooij T, van Hilst J, van Santvoort H, Boerma D, van den Boezem P, Daams 
F, et al. Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD): A Multicenter 
Patient-blinded Randomized Controlled Trial. Ann Surg. 2019;269(1):2-9. 
8. 
Björnsson B, Larsson AL, Hjalmarsson C, Gasslander T, Sandström P. 
Comparison of the duration of hospital stay after laparoscopic or open distal pancreatectomy: 
randomized controlled trial. Br J Surg. 2020;107(10):1281-8. 
9. 
Korrel M, Jones LR, van Hilst J, Balzano G, Björnsson B, Boggi U, et al. 
Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer 
(DIPLOMA): an international randomised non-inferiority trial. The Lancet Regional Health – 
Europe. 2023;31. 
10. 
Abu Hilal M, van Ramshorst TME, Boggi U, Dokmak S, Edwin B, Keck T, et 
al. The Brescia Internationally Validated European Guidelines on Minimally Invasive 
Pancreatic Surgery (EGUMIPS). Annals of Surgery. 9900:10.1097/SLA.0000000000006006. 
11. 
Lemmens VE, Bosscha K, van der Schelling G, Brenninkmeijer S, Coebergh 
JW, de Hingh IH. Improving outcome for patients with pancreatic cancer through 
centralization. Br J Surg. 2011;98(10):1455-62. 
12. 
Gooiker GA, Lemmens VE, Besselink MG, Busch OR, Bonsing BA, Molenaar 
IQ, et al. Impact of centralization of pancreatic cancer surgery on resection rates and survival. 
Br J Surg. 2014;101(8):1000-5. 
13. 
Onete VG, Besselink MG, Salsbach CM, Van Eijck CH, Busch OR, Gouma DJ, 
et al. Impact of centralization of pancreatoduodenectomy on reported radical resections rates 
in a nationwide pathology database. HPB (Oxford). 2015;17(8):736-42. 

Study protocol Pancreatic surgery in Iceland, 2023-07-16 
14. 
Korrel M, Lof S, Alseidi AA, Asbun HJ, Boggi U, Hogg ME, et al. Framework 
for Training in Minimally Invasive Pancreatic Surgery: An International Delphi Consensus 
Study. J Am Coll Surg. 2022;235(3):383-90. 
15. 
Icelandic population statistics, overview. Statistics Iceland. 2023 [Available 
from: https://www.statice.is/. 
16. 
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a 
new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 
2004;240(2):205-13. 
17. 
Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, et al. The 
2016 update of the International Study Group (ISGPS) definition and grading of postoperative 
pancreatic fistula: 11 Years After. Surgery. 2017;161(3):584-91. 
18. 
Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, et al. 
Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the 
International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007;142(5):761-8. 
19. 
Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, et al. 
Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery 
(ISGPS) definition. Surgery. 2007;142(1):20-5. 
20. 
Koch M, Garden OJ, Padbury R, Rahbari NN, Adam R, Capussotti L, et al. Bile 
leakage after hepatobiliary and pancreatic surgery: a definition and grading of severity by the 
International Study Group of Liver Surgery. Surgery. 2011;149(5):680-8. 
21. 
Marchegiani G, Barreto SG, Bannone E, Sarr M, Vollmer CM, Connor S, et al. 
Postpancreatectomy Acute Pancreatitis (PPAP): Definition and Grading From the 
International Study Group for Pancreatic Surgery (ISGPS). Ann Surg. 2022;275(4):663-72. 
22. 
van Roessel S, Mackay TM, van Dieren S, van der Schelling GP, Nieuwenhuijs 
VB, Bosscha K, et al. Textbook Outcome: Nationwide Analysis of a Novel Quality Measure 
in Pancreatic Surgery. Ann Surg. 2020;271(1):155-62.