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

NCT ID: NCT03172572

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-04-30

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.

Conditions

Pancreatic Neoplasms; Pancreas Cyst; Pancreas Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Indication for surgery

Solid neoplasms

Minimally invasive pancreatoduodenectomy

Intervention Type: PROCEDURE

Laparoscopic, robot-assisted, or hybrid resection

Open pancreatoduodenectomy

Intervention Type: PROCEDURE

Open resection

Interventions

Minimally invasive pancreatoduodenectomy

Laparoscopic, robot-assisted, or hybrid resection

Intervention Type: PROCEDURE

Open pancreatoduodenectomy

Open resection

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S (Sjors) Klompmaker, MD

OTHER

Sponsor Role: lead

Responsible Party

S (Sjors) Klompmaker, MD

PhD Candidate

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sjors Klompmaker

Amsterdam, , Netherlands

Countries

Netherlands

References

Klompmaker S, van Hilst J, Wellner UF, Busch OR, Coratti A, D'Hondt M, Dokmak S, Festen S, Kerem M, Khatkov I, Lips DJ, Lombardo C, Luyer M, Manzoni A, Molenaar IQ, Rosso E, Saint-Marc O, Vansteenkiste F, Wittel UA, Bonsing B, Groot Koerkamp B, Abu Hilal M, Fuks D, Poves I, Keck T, Boggi U, Besselink MG; European consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Outcomes After Minimally-invasive Versus Open Pancreatoduodenectomy: A Pan-European Propensity Score Matched Study. Ann Surg. 2020 Feb;271(2):356-363. doi: 10.1097/SLA.0000000000002850.

Reference Type: DERIVED

PMID: 29864089 (View on PubMed)

Other Identifiers

W16_401#17.011

Identifier Type: -

Identifier Source: org_study_id