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2019-03-01
2019-12-31
2020-03-01
435
NCT04317352
Universidad de Extremadura
Universidad de Extremadura
OBSERVATIONAL
Multivisceral Resection in Distal Pancreatectomy
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-03-19 | N/A | 2020-03-19 |
2020-03-19 | N/A | 2020-03-23 |
2020-03-23 | N/A | 2020-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Morbidity | Any complication in the postoperative period | 90 days |
| Mortality | If the patient dies in the postoperative period | 90 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
