MI Total Pancreatectomy 2018-02-08T08:43:05+00:00

Short-term outcomes after minimally invasive versus open total pancreatectomy in high-volume centers; a European retrospective propensity-score matched cohort study

PROTOCOL SUMMARY:

Rationale: Minimally-invasive total pancreatectomy (MITP), either laparoscopic or robot-assisted, is a complex surgical procedure that has rarely been reported in the literature. Published articles describe a few cases and conclude that MITP in well selected patients is feasible and safe. However, it remains unclear if it is a true alternative to open total pancreatectomy (OTP). Large cohorts and especially studies comparing MITP and OTP are scarce, and no randomized studies comparing MITP with OTP are available.

Objective: To compare outcomes of MITP versus open total pancreatectomy (OTP) in high-volume centers for minimally-invasive surgery.

Methods: A retrospective multicenter propensity-score matched cohort study including all consecutive patients undergoing MITP or OTP between January 1st 2008 and December 31st 2017, for all indications (pancreatic-, bile duct-, or duodenal cancer, IPMN (intraductal papillary mucinous neoplasm), pNET (pancreatic neuroendocrine tumor), chronic pancreatitis, other). Matching of MITP cases to OTP controls (both collected at participating E-MIPS centers) will be based on propensity scores determined by logistic regression including preoperative variables: treatment center, year of surgery, demographics, type of TP (e.g. elective primary TP, elective completion TP, spleen preserving/ resecting, pylorus preserving/ resecting), BMI, ASA, comorbidities, tumor size, tumor etiology (diagnosis), and multivisceral resection.

Outcomes: Primary outcome is 90-day major morbidity (Clavien-Dindo ≥ 3a) Secondary surgical outcomes are 90-day postoperative events including: length of hospital stay, 90-day mortality, estimated blood loss, and blood transfusion(s). (Oncological outcomes are R0 (microscopically negative) resection margin, malignant lymph node ratio, days to adjuvant therapy. Patient impact variables are endocrine/exocrine insufficiency measurements including: use of insulin-injections or insulin-pump, HbA1c level after 3 months, use of pancreatic enzymes (doses and frequency), and diabetes related events (e.g. emergency room visits, readmissions within 90 days).  Predefined electronic case report forms will be disseminated amongst participating centers. Participants are responsible for their own data collection.

STUDY COORDINATORS:

Lianne Scholten, MD
PhD candidate University of Amsterdam

Sjors Klompmaker, MD
PhD candidate University of Amsterdam

AMC Amsterdam, Department of Surgery, G4-136
PO Box 22660
1100 DD Amsterdam
Tel: +3120-5661388 / +3120-5669111 (pager: 63067)
Contact

SENIOR INVESTIGATORS:

David Fuks, Paris
Ignasi Poves, Barcelona
Tobias Keck, Lubeck
Mo Abu Hilal, Southampton
Marc Besselink, Amsterdam
Ugo Boggi, Pisa

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Events:

2019 E-AHPBA Congress

2 June 2019 - 5 June 2019

Endorsed by:

Swedish Study Group
for Pancreatic Cancer
(SSPAC)