NCT04317352

Brief Summary

The objective of the study is to evaluate the characteristics of the patients and the results of morbidity and mortality after distal pancreatectomy isolated or accompanied by multivisceral resection including cholecystectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
435

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

March 19, 2020

Last Update Submit

March 19, 2020

Conditions

Keywords

Complicationsdistal pancreatectomyMultivisceralresection

Outcome Measures

Primary Outcomes (2)

  • Morbidity

    Any complication in the postoperative period

    90 days

  • Mortality

    If the patient dies in the postoperative period

    90 days

Study Arms (1)

Multivisceral resection (MRV)

MVR: Multivisceral resection was considered when the exeresis of an organ other than the pancreatic body-tail and / or spleen was performed.

Procedure: MVR

Interventions

MVRPROCEDURE

Multivisceral resection was considered when the exeresis of an organ other than the pancreatic body-tail and / or spleen was performed.

Multivisceral resection (MRV)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing distal pancreatectomy for primary pancreatic tumor at participating centers during the period from January 2009 to December 2018

You may qualify if:

  • Any distal pancreatectomy (DP) with multivisceral resection (MVR) defining MVR as any organ different from distal pancreas or spleen

You may not qualify if:

  • Distal Pancreatectomy with celiac trunk resection (Appleby procedure) or portal vein resection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Extremadura- Facultad de Medicina

Badajoz, 06080, Spain

Location

Related Publications (7)

  • Malinka T, Klein F, Andreou A, Pratschke J, Bahra M. Distal Pancreatectomy Combined with Multivisceral Resection Is Associated with Postoperative Complication Rates and Survival Comparable to Those After Standard Procedures. J Gastrointest Surg. 2018 Sep;22(9):1549-1556. doi: 10.1007/s11605-018-3804-z. Epub 2018 May 10.

    PMID: 29748738BACKGROUND
  • Burdelski CM, Reeh M, Bogoevski D, Gebauer F, Tachezy M, Vashist YK, Cataldegirmen G, Yekebas E, Izbicki JR, Bockhorn M. Multivisceral resections in pancreatic cancer: identification of risk factors. World J Surg. 2011 Dec;35(12):2756-63. doi: 10.1007/s00268-011-1263-8.

    PMID: 21938586BACKGROUND
  • Panzeri F, Marchegiani G, Malleo G, Malpaga A, Maggino L, Marchese T, Salvia R, Bassi C, Butturini G. Distal pancreatectomy associated with multivisceral resection: results from a single centre experience. Langenbecks Arch Surg. 2017 May;402(3):457-464. doi: 10.1007/s00423-016-1514-0. Epub 2016 Oct 27.

    PMID: 27787606BACKGROUND
  • Irani JL, Ashley SW, Brooks DC, Osteen RT, Raut CP, Russell S, Swanson RS, Whang EE, Zinner MJ, Clancy TE. Distal pancreatectomy is not associated with increased perioperative morbidity when performed as part of a multivisceral resection. J Gastrointest Surg. 2008 Dec;12(12):2177-82. doi: 10.1007/s11605-008-0605-9. Epub 2008 Aug 2.

    PMID: 18677539BACKGROUND
  • Song KB, Kwon J, Kim YW, Hwang DW, Lee JH, Hong S, Lee JW, Hwang K, Yoo D, Kim SC. Prognostic value of adjacent organ resection in patients with left-sided pancreatic ductal adenocarcinoma following distal pancreatectomy. J Hepatobiliary Pancreat Sci. 2019 Jun;26(6):227-234. doi: 10.1002/jhbp.627. Epub 2019 May 11.

    PMID: 30980486BACKGROUND
  • Nikfarjam M, Sehmbey M, Kimchi ET, Gusani NJ, Shereef S, Avella DM, Staveley-O'Carroll KF. Additional organ resection combined with pancreaticoduodenectomy does not increase postoperative morbidity and mortality. J Gastrointest Surg. 2009 May;13(5):915-21. doi: 10.1007/s11605-009-0801-2. Epub 2009 Feb 7.

    PMID: 19198960BACKGROUND
  • Ramia JM, Del Rio-Martin JV, Blanco-Fernandez G, Cantalejo-Diaz M, Rotellar-Sastre F, Sabater-Orti L, Carabias-Hernandez A, Manuel-Vazquez A, Hernandez-Rivera PJ, Jaen-Torrejimeno I, Kalviainen-Mejia HK, Esteban-Gordillo S, Munoz-Forner E, De la Plaza R, Longoria-Dubocq T, De Armas-Conde N, Pardo-Sanchez F, Garces-Albir M, Serradilla-Martin M. Distal pancreatectomy with multivisceral resection: A retrospective multicenter study - Case series. Int J Surg. 2020 Oct;82:123-129. doi: 10.1016/j.ijsu.2020.08.024. Epub 2020 Aug 26.

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • José Manuel Ramia, MD, PhD

    Hospital Universitario de Guadalajara

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of department

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 23, 2020

Study Start

March 1, 2019

Primary Completion

December 31, 2019

Study Completion

March 1, 2020

Last Updated

March 23, 2020

Record last verified: 2020-03

Locations