Multivisceral Resection in Distal Pancreatectomy

Completed

• Conditions: Surgical Procedure, Unspecified; Pancreatic Neoplasms
• Interventions: Procedure: MVR

• Registration Number: NCT04317352
• Lead Sponsor: Universidad de Extremadura

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.

Detailed 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.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-12-31
• Status Verified: 2020-03
• Study Completion: 2020-03-01
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-19
• Last Update Submitted: 2020-03-19
• Study First Posted: 2020-03-23
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 435

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mortality	90 days	If the patient dies in the postoperative period
Morbidity	90 days	Any complication in the postoperative period

Trial Locations

Locations (1)

Universidad de Extremadura- Facultad de Medicina; 🇪🇸 Badajoz, Spain