Multivisceral Resection in Distal Pancreatectomy

Pancreatic Neoplasms Clinical Trial

— ERPANDIS-MRV  

Official title:

Distal Pancreatectomy With Multivisceral Resection: A Multicentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317352
• Other study ID #: UE-CHU 003-2020
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: Universidad de Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Multicenter study that includes patients operated on for distal pancreatectomy between January 2009 to December 2019 for primary pancreatic tumors. Both open or laparoscopic approaches are considered in the study. The objective 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. For this, demographic data, variables related to the tumor, surgical intervention and postoperative evolution were collected.

Definitions:

Diagnosis was based mainly on computed tomography (CT scan), Magnetic Resonance (MRI) and endoscopic ultrasonography (USE) plus biopsy. Surgical technique includes open and laparoscopic approach with or without spleen preservation. Complications were assessed at 90 days using the Clavien - Dindo classification, and those defined as Clavien - Dindo grade IIIA or higher were considered major. For the recording of complications, the medical and nursing notes of the electronic or histories of each patient were consulted. For the specific complications of pancreatic surgery, the definitions of the International Study Group on Pancreatic Surgery (ISGPS) of delayed gastric emptying (21), post-pancreatic hemorrhage (22) and pancreatic fistula were used. The resection margins of the surgical specimen were categorized according to the definitions of the Royal College of Pathologists: R0 (margin to the tumor ≥ 1mm), R1 (margin to the tumor <1mm) and R2 (macroscopically positive margin) (24). Tumors were staged according to the TNM classification 8 º Ed. (TNM). Follow up scheme was: 6-month outpatient clinic visit during first five years including tumoral markers and CT/MRI. After five years only once a year visit policy was applied.

Variables The following variables were studied: Epidemiological: age, sex, past medical history, medication, Charlson Index and American Society of Anesthesiology (ASA) classification; Clinical: symptoms due to mucinous neoplasm (MCN); Serological tests: leukocytes, amylase; hemoglobin (gr/dl), bilirubin, creatinin, prothrombin time, carcinoembryonic antigen (CEA) and carbohydrate antigen (CA) 19-9; Radiological/diagnostic: diagnostic tests performed (CT/MRI/EUS), number, size and location of MCN, vascular infiltration (arterial and venous) and preoperative biopsy; Surgical: type of approach (open/laparoscopy/conversion), spleen preservation, associated procedures (organs resected), type of closure of pancreatic remnant, intraoperative bleeding (ml); postoperative course: morbidity and mortality (according to the Clavien-Dindo (CD) classification) (13), pancreatic fistula, postoperative hemorrhage and delayed gastric empting, if present, was classified according to the International Group Study Pancreatic Surgery (IGSPS) classification (14,15), hospital stay and readmissions. The histological data retrieved were TNM: tumor size and lymph nodes harvested and R status. Postoperative follow-up (months) including endocrine and exocrine insufficiency rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: March 1, 2020
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Surgical Procedure, Unspecified

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad de Extremadura- Facultad de Medicina	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Extremadura

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Any complication in the postoperative period	90 days
Primary	Mortality	If the patient dies in the postoperative period	90 days