The impact of pancreaticojejunostomy for pancreatic stump during distal pancreatectomy to reduce pancreatic fistula ― A multicenter randomized controlled trial

Pancreatology ◽  
2016 ◽  
Vol 16 (4) ◽  
pp. S37-S38
Author(s):  
Manabu Kawai ◽  
Seiko Hirono ◽  
Ken-ichi Okada ◽  
Masayuki Sho ◽  
Yoshiyuki Nakajima ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pancreatic Fistula ◽  
Distal Pancreatectomy ◽  
Controlled Trial ◽  
Pancreatic Stump ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

A multicenter, randomized, controlled trial comparing the occurrence of major adverse cardiovascular events (MACEs) in patients (pts) with prostate cancer (pc) and cardiovascular disease (CVD) receiving degarelix (GnRH receptor antagonist) or leuprolide (GnRH receptor agonist).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS395-TPS395 ◽  
Author(s):  
Susan F. Slovin ◽  
Chiara Melloni ◽  
Samreen Mansor-Lefebvre ◽  
Anders Neijber ◽  
Matthew Roe
Keyword(s):  
Randomized Controlled Trial ◽  
Gnrh Agonist ◽  
Receptor Agonist ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Gnrh Receptor ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

TPS395 Background: Epidemiological studies showed an association between GnRH agonists and a long-term increased risk of CVD, early after treatment initiation and with a higher risk seen in pts with pre-existing CVD. Retrospective pooled safety analyses of 6 randomized trials showed that significantly fewer pts treated with the GnRH receptor antagonists, degarelix, had a CV event or death compared with pts receiving a GnRH receptor agonist. In those studies showing an increased CV risk, Androgen-Deprivation Therapy (ADT) was primarily with GnRH receptor agonists. The mechanistic differences between GnRH antagonists and agonists, including testosterone surge and time to suppression at initiation, effect on follicle-stimulating hormone and on GnRH receptors e.g. T-lymphocytes in atherosclerotic plaque, raises the possibility of different CV risk profiles. The PRONOUNCE trial is the first to prospectively assess whether a GnRH agonist/antagonist can worsen pre-existing CVD; assess the impact of GnRH agonist/antagonist on CV risk biomarkers; and effects of hormonal therapy on immune system. Methods: PRONOUNCE is a multi-center, randomized, controlled trial of 900 men with pc and concomitant CVD, assessing adjudicated MACEs, i.e. myocardial infarction (fatal, non-fatal), stroke (fatal, non-fatal), or death in pts randomized 1:1 to either degarelix or leuprolide according to label recommendations for up to one year. Eligibility include pre-defined CVD, metastatic or locally advanced pc; high-risk disease with plan for definitive radiation therapy (RT); recurrence after local therapy with PSA doubling time <12 months; or salvage RT with neoadjuvant/adjuvant ADT for at least 12 months. Serum samples are collected for the analysis of various CV, inflammatory, and immune biomarkers. The primary endpoint will be based on Kaplan-Meier estimator of survival function and stratified for age group and region. Interim analysis is scheduled when 50% of MACE events have occurred allowing the DSMB to recommend for sample size correction. Clinical trial information: NCT02663908.

scholarly journals A randomized controlled trial of stapled versus ultrasonic transection in distal pancreatectomy

2021 ◽  
Author(s):  
Luca Landoni ◽  
Matteo De Pastena ◽  
Martina Fontana ◽  
Giuseppe Malleo ◽  
Alessandro Esposito ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pancreatic Fistula ◽  
Distal Pancreatectomy ◽  
Controlled Trial ◽  
Intraoperative Ultrasound ◽  
Postoperative Pancreatic Fistula ◽  
Ultrasonic Dissection ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Secondary Endpoints

Abstract Background The pancreatic transection method during distal pancreatectomy is thought to influence postoperative fistula rates. Yet, the optimal technique for minimizing fistula occurrence is still unclear. The present randomized controlled trial compared stapled versus ultrasonic transection in elective distal pancreatectomy. Methods Patients undergoing distal pancreatectomy from July 2018 to July 2020 at two high-volume institutions were considered for inclusion. Exclusion criteria were contiguous organ resection and a parenchymal thickness > 17 mm on intraoperative ultrasound. Eligible patients were randomized in a 1:1 ratio to stapled transection (Endo GIA Reinforced Reload with Tri-Staple Technology®) or ultrasonic transection (Harmonic Focus® + or Harmonic Ace® + shears). The primary endpoint was postoperative pancreatic fistula. Secondary endpoints included overall complications, abdominal collections, and length of hospital stay. Results Overall, 72 patients were randomized in the stapled transection arm and 73 patients in the ultrasonic transection arm. Postoperative pancreatic fistula occurred in 23 patients (16%), with a comparable incidence between groups (12% in stapled transection versus 19% in ultrasonic dissection arm, p = 0.191). Overall complications did not differ substantially (35% in stapled transection versus 44% in ultrasonic transection arm, p = 0.170). There was an increased incidence of abdominal collections in the ultrasonic dissection group (32% versus 14%, p = 0.009), yet the need for percutaneous drain did not differ between randomization arms (p = 0.169). The median length of stay was 8 days in both groups (p = 0.880). Intraoperative blood transfusion was the only factor independently associated with postoperative pancreatic fistula on logistic regression analysis (OR 4.8, 95% CI 1.2–20.0, p = 0.032). Conclusion The present randomized controlled trial of stapled versus ultrasonic transection in elective distal pancreatectomy demonstrated no significant difference in postoperative pancreatic fistula rates and no substantial clinical impact on other secondary endpoints.

scholarly journals The effectiveness of a web-based decision aid for patients with hip osteoarthritis: study protocol for a randomized controlled trial.

2020 ◽  
Author(s):  
Lilisbeth Perestelo-Perez ◽  
Yolanda Alvarez-Perez ◽  
Amado Rivero-Santana ◽  
Vanesa Ramos-García ◽  
Andrea Duarte-Díaz ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Options ◽  
Hip Osteoarthritis ◽  
Decision Making Process ◽  
Web Based ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

Abstract Background: Osteoarthritis (OA) is a health condition sensitive to patient’s preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs and preferences into the decision-making process, thus improving Person-Centred Care. Previous research has focused almost exclusively on knee OA, and therefore the aim of this study is to develop and evaluate the effectiveness of a PtDA for patients with hip OA.Methods: The general design consists of two phases: 1) design a web-based PtDA for patients with hip OA, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an Advisory Committee composed of health professionals and patients; 2) To evaluate the impact of the PtDA on hip OA patients’ decision-making process related with their treatment. For that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care.Discussion: PtDAs have been recommended as a useful and effective resource for improving PCC in many health conditions. The intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment, and by ensuring they make informed decisions congruent with their values and preferences. This study will contribute to the scientific knowledge about effectiveness of PtDAs in hip OA, in order to improve the quality of health care offered to these patients.Trial registration: ClinicalTrials.gob (NCT04241978). Registered on 24 January 2020.

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