Thunderbeat™ Integrated Bipolar and Ultrasonic Forceps in the Whipple Procedure: A Prospective Randomized Trial.
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SUBMITTER: James CA
PROVIDER: S-EPMC7721432 | biostudies-literature | 2020 Nov-Dec
REPOSITORIES: biostudies-literature
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Thunderbeat™ Integrated Bipolar and Ultrasonic Forceps in the Whipple Procedure: A Prospective Randomized Trial.
James C Alston CA Williams Gregory A GA Jin Linda X LX Liu Jingxia J Sanford Dominic E DE Fields Ryan C RC Doyle Majella M B MMB Strasberg Steven M SM Hawkins William G WG Hammill Chet W CW
Missouri medicine 20201101 6
Thunderbeat™ is a device that uses both ultrasonic and advanced bipolar energies to achieve hemostasis. It has been evaluated in a variety of clinical contexts, but no literature exists regarding its application to pancreatic surgery. Using a prospective, randomized controlled trial, we evaluated its safety and efficacy in the Whipple procedure. Thirty-two participants were enrolled in the study. The Thunderbeat™ device during the Whipple procedure showed similar safety profile compared to stand ...[more]
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Project description:BackgroundThe World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, procedure time, and cost) of the PrePex device compared to forceps-guided surgical circumcision.Methods and findingsThis Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the procedures. The PrePex device procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total procedure time for the PrePex device was approximately one-third of the total surgical procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p<0.00001). There were 2 AEs for 2 participants (rate of 1.3%, 95% Confidence Interval: 0.0025-4.53%), which were resolved with simple intervention. The AEs were device related, including 1 case of pain leading to device removal and 1 case of removal of the device.ConclusionsThe trial supports previous studies' conclusions that the PrePex procedure is safe, quick, easy to apply, and effective in terms of procedure time as an alternative to traditional surgical circumcision. The PrePex device has great potential for use in overburdened health systems and in resource-limited settings and is recommended for use in rapid scale-up of adult MC in Zimbabwe.Trial registrationClinicalTrials.gov NCT01956370.
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Project description:BackgroundHigh-energy devices allow better vessel sealing compared with monopolar electrocautery and could improve the outcomes of surgical operations. The objective of the study was to compare tissue dissection by the LigaSure™ device with that by monopolar electrocoagulation for thoracoscopic lobectomy and lymphadenectomy.MethodsThis pragmatic, parallel group, prospective randomized controlled trial was funded by the Medtronic External Research Program (ISR-2016-10,756) and registered at www.Clinicaltrialsgov (NCT03125798). The study included patients aged 18 years or older, who had undergone thoracoscopic lobectomy with lymphadenectomy at the Department of Thoracic Surgery of Poznan University of Medical Sciences between May 3, 2018, and November 4, 2021. Using simple randomization, the patients were assigned to undergo tissue dissection with either the LigaSure device (study group) or monopolar electrocautery (control group). Participants and care givers, except operating surgeons, were blinded to group assignment. The primary outcome was postoperative chest drainage volume. Secondary outcomes were change of the esophageal temperature during subcarinal lymphadenectomy and C-reactive protein level 72 h after surgery.ResultsStudy outcomes were analyzed in 107 patients in each group. We found no differences between the study and control groups in terms of chest drainage volume (550 vs. 600 mL, respectively; p = 0.315), changes in esophageal temperature (- 0.1 °C vs. - 0.1 °C, respectively; p = 0.784), and C-reactive protein levels (72.8 vs. 70.8 mg/L, respectively; p = 0.503). The mean numbers of lymph nodes removed were 12.9 (SD: 3.1; 95% CI, 12.4 to 13.5) in the study group and 11.6 (SD: 3.2; 95% CI, 11.0 to 12.2) in the control group (p < 0.001).ConclusionsThe use of the LigaSure device did not allow to decrease the chest drainage volume, local thermal spread, and systemic inflammatory response. The number of lymph nodes removed was higher in patients operated with the LigaSure device, which indicated better quality of lymphadenectomy.
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Project description: Not available
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Project description:We report a case of a woman with a medical history of classic Whipple surgery who underwent endoscopic ultrasound (EUS)-guided pancreatic drainage due to smouldering acute pancreatitis secondary to an obstructing pancreatic ductal stone. A gastro-pancreaticojejunostomy anastomosis was created anterogradely, with dilation of both the anastomoses in the same procedure, with subsequent decompression of the pancreatic duct. Endoscopic retrograde pancreatography (ERP) is often impossible to perform in patients with post-Whipple procedure anatomy due to inaccessibility to the pancreaticojejunostomy anastomosis. EUS-guided pancreatic drainage may be offered in these patients in whom the pancreatic duct cannot be accessed at ERP. It has been used as a platform for access to and drainage of the pancreatic duct either by rendezvous or transmural drainage. However, only one of four patients achieve successful completion of the rendezvous procedure. There are limited data regarding safety and long-term outcome of this procedure, as well as scant guidelines on the optimal time for leaving stents in place. We believe definitive endoscopic therapy should be attempted, whenever possible, after relief of obstruction. In our case, we expect that stent occlusion is inevitable and that long-term drainage is possible due to drainage occurring between the stent and the stone.
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Project description:PurposePylorus-preserving pancreatoduodenectomy (PPPD) has been the gold standard for pancreatic head lesion resection for several years. Some studies have noted that it involves more delayed gastric emptying (DGE) than classical Whipple (i.e., pancreatoduodenectomy with antrectomy). Our working hypothesis was that the classical Whipple has a lower incidence of DGE. We aimed to compare the incidence of DGE among pancreatoduodenectomy techniques.MethodsThis pragmatic, randomized, open-label, single-center clinical trial involved patients who underwent classical Whipple (study group) or PPPD (control group). Gastric emptying was clinically evaluated using scintigraphy. DGE was defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria. The secondary endpoints were postoperative morbidity, length of hospital stay, anthropometric measurements, and nutritional status.ResultsA total of 84 patients were randomized (42 per group). DGE incidence was 50% (20/40, 95% confidence interval (95% CI): 35-65%) in the study group and 62% (24/39, 95% CI: 46-75%) in the control group (p = 0.260). No differences were observed between both groups regarding postoperative morbidity or length of hospital stay. Anthropometric measurements at 6 months post-surgery: triceps fold measurements were 12 mm and 16 mm (p = 0.021). At 5 weeks post-surgery, triceps fold measurements were 13 mm and 16 mm (p = 0.020) and upper arm circumferences were 26 cm and 28 cm (p = 0.030). No significant differences were observed in nutritional status.ConclusionDGE incidence and severity did not differ between classical Whipple and PPPD. Some anthropometric measurements may indicate a better recovery with PPPD.Trial registrationClinicalTrials.gov Identifier: NCT03984734.
| S-EPMC9468034 | biostudies-literature