A Pan-European Study on Minimally Invasive Versus Open Pancreatoduodenectomy in High-volume Centers

Completed

• Conditions: Pancreas Cyst; Pancreatic Neoplasms; Pancreas Cancer
• Interventions: Procedure: Minimally invasive pancreatoduodenectomy; Procedure: Open pancreatoduodenectomy

• Registration Number: NCT03172572
• Lead Sponsor: S (Sjors) Klompmaker, MD

Brief Summary

RATIONALE: Minimally-invasive pancreatoduodenectomy (MIPD), either laparoscopic or robot-assisted, has been suggested as a valuable alternative to open pancreatoduodenectomy (OPD). The generalizability of the current literature is, however, unknown since randomized studies are lacking, and current data are published from few, very high volume centers and selection bias with a lack of case-matched series. International studies are lacking completely.

OBJECTIVE: To compare outcomes of MIPD versus open pancreatoduodenectomy (OPD), in high-volume European pancreas centers (\>10 MIPDs per year, total \>20 PDs per year).

METHODS: A retrospective multicenter propensity-score matched cohort study including all consecutive patients who underwent MIPD (or MI total pancreatectomy) between January 2012 and December 2016, for pancreatic head, bile duct, or duodenal cancer or cysts except chronic pancreatitis. Predefined electronic case report forms will be disseminated amongst participating centers. Participants are responsible for their own data collection. Matching of MIPD cases (collected from participating centers) to OPD controls (extracted from Dutch and German national registries) will be based on propensity scores determined by logistic regression including preoperative variables: year of surgery, demographics, BMI, ASA, comorbidities, tumor size, tumor etiology (diagnosis), and multivisceral resection. Primary outcome is 90-day major morbidity(Clavien-Dindo ≥ 3a). Secondary outcomes are 90-day postoperative events including: pancreatic fistula, length of hospital stay, R0 (microscopically negative) resection margin, malignant lymph node ratio, days to adjuvant therapy and overall survival.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-06-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-04-30
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4220

Inclusion Criteria

• Indication for open or minimally invasive pancreatoduodenectomy
• Pancreatic head, bile duct, or duodenal cancer or cysts

Exclusion Criteria

• Chronic pancreatitis without suspected solid tumor.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Indication for surgery	Open pancreatoduodenectomy	Solid neoplasms
Indication for surgery	Minimally invasive pancreatoduodenectomy	Solid neoplasms

Primary Outcome Measures

Name	Time	Method
Major morbidity	90-days	Clavien-Dindo grade 3a-5 complications

Secondary Outcome Measures

Name	Time	Method
Length of stay	90-days	length of hospital stay
Radical resection rate	90-days	R0/R1/R2 classification
Malignant lymph node ratio	90-days	Malignant/ non-malignant lymph nodes
time to adjuvant therapy	90-days	Resection to adjuvant chemo(-radio) therapy
Pancreatic fistulae	90-days	ISGPS 2017 definition
Overall survival	90-days

Trial Locations

Locations (1)

Sjors Klompmaker; 🇳🇱 Amsterdam, Netherlands