scholarly journals Monitoring of patients with microdialysis following pancreaticoduodenectomy—the MINIMUM study: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Espen Lindholm ◽  
Nil Ekiz ◽  
Tor Inge Tønnessen
Keyword(s):  
Length Of Stay ◽  
Pancreatic Fistula ◽  
Standard Of Care ◽  
Postoperative Pancreatic Fistula ◽  
Microdialysis Catheter ◽  
Current Standard ◽  
Randomized Controlled ◽  
Total Length ◽  
Catheter Malfunction ◽  
Patient Reported

Abstract Background Postoperative pancreatic fistula after pancreatoduodenectomy is a much-feared complication associated with substantial mortality and morbidity. The current standard for diagnosing postoperative pancreatic fistula, besides routine clinical examination, include radiological examinations, analysis of pancreatic drain amylase activity, and routine blood samples. Another promising method is by intraperitoneal microdialysis to monitor intraperitoneal metabolites measured at the pancreaticojejunostomy, thereby detecting what occurs locally, before chemical events can be reflected as measurable changes in systemic blood levels. Methods The MINIMUM study is a prospective, randomized, controlled, single center enrolling 200 patients scheduled for open pancreatoduodenectomy comparing the microdialysis method to the “standard of care.” Half of the included patients will be randomized to receive an intraperitoneal microdialysis catheter implanted at the end of surgery and will be monitored by microdialysis as an additional monitoring tool. The other half of the patients will not receive a microdialysis catheter and will be monitored according to the current standard of care. The primary objective is to evaluate if the microdialysis method can reduce the total length of stay at the hospital. Secondary endpoints are the frequency of complications, length of stay at the hospital at our institution, catheter malfunction, number of infections and bleeding episodes caused by the microdialysis catheter, patient-reported quality of life and pain, and cost per patient undergoing pancreatoduodenectomy. The patients will be randomized in a 1:1 ratio. Discussion Intraabdominal microdialysis could potentially reduce morbidity and mortality after pancreatoduodenectomy. Furthermore, there is a great potential for shortening the in-hospital length of stay and reducing the financial aspect considerably. This study may potentially open the possibility for using microdialysis as standard monitoring in patients undergoing pancreatoduodenectomy. The hypothesis is that the microdialysis method compared to “standard care” will reduce the total length of hospital stay. Trial registration Clinicaltrials.gov (NCT03631173). Registered on 7 September 2018 under the name: “Monitoring of patients With Microdialysis Following Pancreaticoduodenectomy”. Based on protocol version 19-1, dated 15th January 2019.

scholarly journals The modified Blumgart anastomosis after pancreaticoduodenectomy: a retrospective single center cohort study

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Georgi Kalev ◽  
Christoph Marquardt ◽  
Herbert Matzke ◽  
Paul Matovu ◽  
Thomas Schiedeck
Keyword(s):  
Length Of Stay ◽  
Hospital Mortality ◽  
Hospital Stay ◽  
Pancreatic Fistula ◽  
Pancreatic Head ◽  
Suture Technique ◽  
Postoperative Pancreatic Fistula ◽  
Intermediate Care ◽  
Pancreatic Head Resection ◽  
Pancreatic Anastomosis

AbstractObjectivesThe postoperative pancreatic fistula (POPF) is a major complication after pancreatic head resection whereby the technique of the anastomosis is a very influencing factor. The literature describes a possible protective role of the Blumgart anastomosis.MethodsPatients after pancreatic head resection with reconstruction through the modified Blumgart anastomosis (a 2 row pancreatic anastomosis through mattress sutures of the parenchyma and duct to mucosa pancreaticojejunostomy, Blumgart-group) were compared with patients after pancreatic head resection and reconstruction through the conventional pancreatojejunostomy (single suture technique of capsule and parenchyma to seromuscularis, PJ-group). The Data were collected retrospectively. Depending on the propensity score matching in a ratio of 1:2 comparison groups were set up. Blumgart-group (n=29) and PJ-group (n=56). The primary end point was the rate of POPF. Secondary goals were duration of operation, length of hospital stay, length of stay on intermediate care units and hospital mortality.ResultsThe rate of POPF (biochemical leak, POPF “grade B” and POPF “grade C”) was less in the Blumgart-group, but without statistical relevance (p=0.23). Significantly less was the rate of POPF “grade C” in the Blumgart-group (p=0.03). Regarding the duration of hospital stay, length of stay on intermediate care units and hospital mortality, there was no relevant statistical difference between the groups (p=0.1; p=0.4; p=0.7). The duration of the operation was significantly less in the Blumgart-group (p=0.001).ConclusionsThe modified Blumgart anastomosis technique may have the potential to decrease major postoperative pancreatic fistula.

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 Use of Hemopatch as a Sealant at the Pancreatojejunostomy to Prevent Postoperative Pancreatic Fistula: A Randomized Controlled Trial

HPB ◽  
2021 ◽  
Vol 23 ◽  
pp. S750-S751
Author(s):  
M. Serradilla-Martín ◽  
M. Cantalejo-Díaz ◽  
S. Paterna-López ◽  
A. Palomares-Cano ◽  
T. Abadía-Forcén ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pancreatic Fistula ◽  
Controlled Trial ◽  
Postoperative Pancreatic Fistula ◽  
Randomized Controlled

Article Commentary: Risk Factors of Pancreatic Fistula after Pancreaticoduodenectomy: A Collective Review

2011 ◽  
Vol 77 (3) ◽  
pp. 257-269 ◽  
Author(s):  
Giovanni Ramacciato ◽  
Paolo Mercantini ◽  
Niccolò Petrucciani ◽  
Giuseppe R. Nigri ◽  
Andrea Kazemi ◽  
...  
Keyword(s):  
Risk Factors ◽  
Surgical Technique ◽  
Length Of Stay ◽  
Pancreatic Fistula ◽  
Perioperative Management ◽  
Meta Analysis ◽  
Postoperative Pancreatic Fistula ◽  
Diagnosis And Treatment ◽  
Current Evidence ◽  
The Ideal

Postoperative pancreatic fistula (POPF) is the most frequent complication after pancreaticoduodenectomy, results in increased morbidity and mortality, and adversely affects length of stay and costs. Reported rates of postoperative pancreatic fistula vary from 0 per cent up to more than 30 per cent. Plenty of randomized trails and meta-analysis were published to analyze the ideal procedure, technique of anastomosis, and perioperative management of patients undergoing pancreaticoduodenectomy; however, results are often discordant and clear evidence on the ideal management and surgical technique to reduce POPF rate is not yet provided. This collective review examined the current evidence about risk factors contributing to postoperative pancreatic fistula and delineates methods of diagnosis and treatment of this universally dreaded complication.

Encorafenib plus cetuximab with or without binimetinib for BRAF V600E-mutant metastatic colorectal cancer: Quality-of-life results from a randomized, three-arm, phase III study versus the choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4039-4039 ◽  
Author(s):  
Scott Kopetz ◽  
Axel Grothey ◽  
Eric Van Cutsem ◽  
Rona Yaeger ◽  
Harpreet Singh Wasan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Standard Of Care ◽  
Current Standard ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Euroqol 5D ◽  
Eortc Qlq ◽  
Triplet Regimen

4039 Background: In the BEACON CRC study, the triplet regimen of encorafenib (ENCO) + binimetinib (BINI) + cetuximab (CETUX) significantly improved overall survival (OS, HR:0.52, P < 0.0001) and objective response rates (ORR, 26% vs 2%, P < 0.0001) in patients (pts) with BRAFV600E metastatic colorectal cancer (mCRC) compared with current standard of care. This analysis focuses on the patient-reported quality of life (QOL) assessments from this study. Methods: The BEACON CRC study was a randomized, open-label, 3-arm, phase 3 global study which evaluated triplet (ENCO+BINI+CETUX) or doublet (ENCO+CETUX) vs. investigator’s choice of irinotecan + CETUX or FOLFIRI + CETUX in pts with BRAFV600E mCRC. QOL assessments (secondary endpoints in the trial) included the EORTC QOL Questionnaire (QLQ C30), Functional Assessment of Cancer Therapy Colon Cancer (FACT C), EuroQol 5D 5L, and Patient Global Impression of Change (PGIC). The primary assessment for the QOL variables was the time to definitive 10% deterioration. The study is ongoing. Results: 665 pts were randomly assigned to receive either triplet (n = 224), doublet (n = 220), or control (n = 221). Reduction in the risk of QOL deterioration was an estimated 45% (HR 0.55, 95% CI: 0.43, 0.70) and 52% (HR 0., 9485% CI: 0.38, 0.62) in EORTC QLQ C30 and FACT C assessments, respectively, in favor of the triplet regimen over control. For the doublet vs. control, reduction in risk of QOL deterioration was an estimated 46% (HR 0.54, 95% CI: 0.43, 0.69) and 54% (HR 0.46, 95% CI: 0.36, 0.59) in EORTC QLQ C30 and FACT C, respectively in favor of the doublet. Similar results were observed in EuroQol 5D 5L and PGIC assessments. There were no overall differences in QOL between triplet and doublet across the 4 instruments. Conclusions: In BEACON CRC, triplet and doublet demonstrated substantial improvement in patient-reported QOL assessments over the current standard of care in pts with BRAFV600E-mutant metastatic CRC whose disease had progressed after 1 or 2 prior regimens. Clinical trial information: NCT02928224 .

Encorafenib plus cetuximab with or without binimetinib for BRAF V600E-mutant metastatic colorectal cancer: Quality-of-life results from a randomized, three-arm, phase III study versus the choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 8-8 ◽  
Author(s):  
Scott Kopetz ◽  
Axel Grothey ◽  
Eric Van Cutsem ◽  
Rona Yaeger ◽  
Harpreet Singh Wasan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Standard Of Care ◽  
Braf V600e ◽  
Current Standard ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Euroqol 5D ◽  
Eortc Qlq ◽  
Triplet Regimen

8 Background: In the BEACON CRC study, the triplet regimen of encorafenib (ENCO) + binimetinib (BINI) + cetuximab (CETUX) significantly improved overall survival (OS, HR:0.52, P < 0.0001) and objective response rates (ORR, 26% vs 2%, P < 0.0001) in patients (pts) with BRAF V600E metastatic colorectal cancer (mCRC) compared with current standard of care. This analysis focuses on the patient-reported quality of life (QOL) assessments from this study. Methods: The BEACON CRC study was a randomized, open-label, 3-arm, phase 3 global study which evaluated triplet (ENCO+BINI+CETUX) or doublet (ENCO+CETUX) vs. investigator’s choice of irinotecan + CETUX or FOLFIRI + CETUX in pts with BRAFV600E mCRC. QOL assessments (secondary endpoints in the trial) included the EORTC QOL Questionnaire (QLQ C30), Functional Assessment of Cancer Therapy Colon Cancer (FACT C), EuroQol 5D 5L, and Patient Global Impression of Change (PGIC). The primary assessment for the QOL variables was the time to definitive 10% deterioration between arms. Results: 665 pts were randomly assigned to receive either triplet (n = 224), doublet (n = 220), or control (n = 221). Reduction in the risk of QOL deterioration was an estimated 45% (HR 0.55, 95% CI: 0.43, 0.70) and 44% (HR 0.56, 95% CI: 0.44, 0.71) in EORTC QLQ C30 and FACT C assessments, respectively, in favor of the triplet regimen over control. For the doublet vs. control, reduction in risk of QOL deterioration was an estimated 46% (HR 0.54, 95% CI: 0.43, 0.69) and 43% (HR 0.57, 95% CI: 0.45, 0.72) in EORTC QLQ C30 and FACT C, respectively in favor of the doublet. Similar results were observed in EuroQol 5D 5L and PGIC assessments. There were no overall differences in QOL between triplet and doublet across the 4 instruments. Conclusions: In BEACON CRC, triplet and doublet demonstrated substantial improvement in patient-reported QOL assessments over the current standard of care in pts with BRAF V600E-mutant metastatic CRC whose disease had progressed after 1 or 2 prior regimens. Clinical trial information: NCT02928224.

scholarly journals Shorter Total Length of Stay After Intraperitoneal Fosfomycin, Metronidazole, and Molgramostim for Complicated Appendicitis: A Pivotal Quasi-Randomized Controlled Trial

2020 ◽  
Vol 7 ◽  
Author(s):  
Siv Fonnes ◽  
Søren Roepstorff ◽  
Barbara Juliane Holzknecht ◽  
Christoffer Skov Olesen ◽  
Joachim Hjalde Halmsted Olsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Length Of Stay ◽  
Controlled Trial ◽  
Complicated Appendicitis ◽  
Randomized Controlled ◽  
Total Length

scholarly journals Virtual controls as an alternative to randomized controlled trials for assessing efficacy of interventions

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Joseph M. Strayhorn
Keyword(s):  
Randomized Controlled Trials ◽  
Clinical Information ◽  
Standard Of Care ◽  
Treatment Decisions ◽  
Individual Treatment ◽  
Controlled Trials ◽  
Current Standard ◽  
Randomized Controlled ◽  
Track Record ◽  
Randomized Design

AbstractRandomized controlled trials are ubiquitously spoken of as the “gold standard” for testing interventions and establishing causal relations. This article presents evidence for two premises. First: there are often major problems with randomized designs; it is by no means true that the only good design is a randomized design. Second: the method of virtual controls in some circumstances can and should replace randomized designs.Randomized trials can present problems with external validity or generalizability; they can be unethical; they typically involve much time, effort, and expense; their assignments to treatment conditions often can be maintained only for limited time periods; examination of their track record reveals problems with reproducibility on the one hand, and lack of overwhelming superiority to observational methods on the other hand.The method of virtual controls involves ongoing efforts to refine statistical models for prediction of outcomes from measurable variables, under conditions of no treatment or current standard of care. Research participants then join a single-arm study of a new intervention. Each participant’s data, together with the formulas previously generated, predict that participant’s outcome without the new intervention. These outcomes are the “virtual controls.” The actual outcomes with intervention are compared with the virtual control outcomes to estimate effect sizes. Part of the research product is the prediction equations themselves, so that in clinical practice, individual treatment decisions may be aided by quantitative answers to the questions, “What is estimated to happen to this particular patient with and without this treatment?”The method of virtual controls is especially indicated when rapid results are of high priority, when withholding intervention is likely harmful, when adequate data exist for prediction of untreated or standard of care outcomes, when we want to let people choose the treatment they prefer, when tailoring treatment decisions to individuals is desirable, and when real-world clinical information can be harnessed for analysis.

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