Distal pancreatectomy, minimally invasive or open, for malignancy

Conditions

Proven or suspected pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail suitable for elective upfront distal pancreatectomy Surgery

Bruna CL, van Hilst J, Korrel M, Jones LR, Balzano G, Björnsson B, Boggi U, Bratlie SO, Busch OR, Butturini G, Capretti G, Casadei R, Dokmak S, Edwin B, Esposito A, Falconi M, Ferrari G, Hackert T, Kazemier G, Koerkamp BG, de Kleine RH, Keck T, Kleive DB, Kokkola A, Kooby D, Lips DJ, Luyer MDP, Guerra M, Marudanayagam R, Menon K, Molenaar IQ, de Pastena M, Pecorelli N, Primrose JN, Ricci C, Saint Marc O, Salvia R, Sandström P, Tomazic A, Wellner UF, Yip VS, Zerbi A, Ali M, Dijkgraaf MGW, Besselink MG, Abu Hilal M, European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS).

2025-12-011 citations

10.1001/jamasurg.2025.4054

Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trial.

Korrel M, Jones LR, van Hilst J, Balzano G, Björnsson B, Boggi U, Bratlie SO, Busch OR, Butturini G, Capretti G, Casadei R, Edwin B, Emmen AMLH, Esposito A, Falconi M, Groot Koerkamp B, Keck T, de Kleine RHJ, Kleive DB, Kokkola A, Lips DJ, Lof S, Luyer MDP, Manzoni A, Marudanayagam R, de Pastena M, Pecorelli N, Primrose JN, Ricci C, Salvia R, Sandström P, Vissers FLIM, Wellner UF, Zerbi A, Dijkgraaf MGW, Besselink MG, Abu Hilal M, European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS).

2023-07-0672 citations

10.1016/j.lanepe.2023.100673

Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): An international randomised trial.

Mohammad Abu Hilal, Maarten Korrel, L. Jones, Jony van Hilst, Bergþór Björnsson et al. (20 authors)

Journal of Clinical Oncology2023-06-011 citations

10.1200/jco.2023.41.16_suppl.4163

Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial

Jony van Hilst, Maarten Korrel, Sanne Lof, Thijs de Rooij, Frederique L. Vissers et al. (52 authors)

Trials2021-09-0937 citations

10.1186/s13063-021-05506-z

Establishing and Coordinating a Nationwide Multidisciplinary Study Group: Lessons Learned by the Dutch Pancreatic Cancer Group

Marin Strijker, Tara M. Mackay, Bert A. Bonsing, Marco J. Bruno, Casper H.J. van Eijck et al. (15 authors)

Annals of Surgery2020-02-2173 citations

10.1097/sla.0000000000003779

DIPLOMA Approach for Standardized Pathology Assessment of Distal Pancreatectomy Specimens

Sanne Lof, Rushda Rajak, Frederique L. Vissers, Maarten Korrel, Adrian C Bateman et al. (10 authors)

Journal of Visualized Experiments2020-02-019 citations

10.3791/60343

DIPLOMA Approach for Standardized Pathology Assessment of Distal Pancreatectomy Specimens

Sanne Lof, Rushda Rajak, Frederique L. Vissers, Maarten Korrel, Adrian C Bateman et al. (10 authors)

Journal of Visualized Experiments2020-02-016 citations

10.3791/60343-v

Interventions

This study is designed for patients with an indication for distal pancreatectomy because of proven or suspected PDAC in the pancreatic body or tail. After inclusion, patients are randomly allocated in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria: 1. Age =18 years 2. Elective indication for distal pancreatectomy for proven or suspected* PDAC 3. Upfront (without induction/downsizing radio- or chemotherapy) resectable PDAC in the pancreatic body or tail** 4. The tumor can be radically resected via both minimally invasive or open surgery according to the local treating team*** 5. The patient is fit to undergo both open and minimally invasive distal pancreatectomy *Pathology proof is not mandatory for two reasons, first it is not common practice in distal cancers to have this proof, so the decision for minimally invasive or open surgery will after the trial also depend on the ‘suspected’ diagnosis and second, there are even some concerns about the safety of endoscopic fine needle aspiration of distal pancreatic cancers with theoretical risk of peritoneal seeding **Malignant degenerated cysts are not allowed in the study. Neoadjuvant chemotherapy is only allowed in case of an upfront resectable tumor (neoadjuvant) **Multivisceral resections are allowed if, according to the local treating team, feasible with both, a minimally invasive and open approach

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 19/05/2020: Patients that meet any of the following criteria will be excluded from participation in this study: 1. American Society of Anesthesiologists classification >3 2. A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria) 3. Second malignancy necessitating resection during the same procedure 4. Distant metastases (M1) including involved distant lymph nodes 5. Tumor involvement or abutment of major vessels (celiac trunk*, mesenteric artery or portomesenteric vein); 6. Pregnancy 7. Participation in another study with interference of study outcomes *The celiac trunk should be 5mm clear from tumor Previous exclusion criteria: Patients that meet any of the following criteria will be excluded from participation in this study: 1. ASA >3 (see appendix 17.3.2) 2. A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria, see Appendix for detailed definition) 3. Second malignancy necessitating resection during the same procedure 4. Radiotherapy because of pancreatic cancer prior to distal pancreatectomy 5. Distant metastases (M1) including involved distant lymph nodes 6. Tumor involvement or abutment of major vessels (celiac trunk*, mesenteric artery or portomesenteric vein); 7. Pregnancy 8. Participation in another study with interference of study outcomes *The celiac trunk should be 5mm clear from tumor

Design outcomes

Primary

Measure	Time frame
Microscopically radical resection margin (R0) (these can be in the transection margin of the pancreas but also in the anterior, superior, posterior, inferior margins, i.e. circumferential margins); Timepoint: postoperative	—

Secondary

Measure	Time frame
1. Intraoperative parameters (operative time, blood loss, blood transfusion and conversion) 2. Postoperative parameters (complications, mortality, re-interventions) 3. Pathology parameters (tumor size, lymph node retrieval, positive nodes, invasion, grading and staging) 4. Hospitalization parameters (time to functional recovery [measured daily using the functional recovery checklist], total hospital stay, readmission, intensive care admission) 5. Oncology parameters (use of (neo-)adjuvant chemotherapy, survival at 1, 2 and 3 years postoperative) 6. Quality of life, measured using the EORTC QLQ-30 and PAN-26 and EQ-5D-5L questionnaires at baseline and 1, 3 and 6 months postoperative 7. Costs	—

Measure

Time frame

1. Intraoperative parameters (operative time, blood loss, blood transfusion and conversion) 2. Postoperative parameters (complications, mortality, re-interventions) 3. Pathology parameters (tumor size, lymph node retrieval, positive nodes, invasion, grading and staging) 4. Hospitalization parameters (time to functional recovery [measured daily using the functional recovery checklist], total hospital stay, readmission, intensive care admission) 5. Oncology parameters (use of (neo-)adjuvant chemotherapy, survival at 1, 2 and 3 years postoperative) 6. Quality of life, measured using the EORTC QLQ-30 and PAN-26 and EQ-5D-5L questionnaires at baseline and 1, 3 and 6 months postoperative 7. Costs

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Countries

Belgium, England, France, Germany, Italy, Netherlands, Norway, Russian Federation, Slovenia, Spain, Sweden, United Kingdom, United States of America, Wales

Outcome results

None listed