Dataset Information

2-octyl cyanoacrylate sealing of the pancreatic remnant after distal pancreatectomy - A prospective pilot study.

ABSTRACT:

Background

Postoperative pancreatic fistula (POPF) remains a frequent problem especially after distal pancreatectomy. The application of 2-octyl cyanoacrylate showed promising results in the reduction of POPF after pancreatoduodenectomy prompting an expansion of this technique to distal pancreatectomy. Thus, the objective of the current study was to assess safety, feasibility and preliminary efficacy of an intraoperative 2-octyl cyanoacrylate application after distal pancreatectomy.

Methods

Between April 2015 and June 2016 adult patients scheduled for elective distal pancreatectomy were considered eligible for the study. It was planned to include a total of 35 patients. After distal pancreatectomy with hand-sewn closure of the pancreatic remnant, a 2-octyl cyanoacrylate surgical glue was applied to the cut surface of the pancreas. Patients were followed up for three months with main focus on safety in terms of (serious) adverse events. Further endpoints included POPF, other pancreas-specific and surgical complications.

Results

15 patients were included in the study because the manufacturer stopped production and distribution of the investigational device thereafter. There was a total of ten serious adverse events but no device-related events and no mortality. The serious adverse events depicted a typical safety profile after distal pancreatectomy. POPF occurred in five cases (33.3%), delayed gastric emptying and post-pancreatectomy haemorrhage in two cases respectively (13.3%).

Conclusions

Application of 2-octyl cyanoacrylate to the pancreatic remnant after distal pancreatectomy seems feasible and safe. The planned evaluation of preliminary efficacy was not possible due to the inadvertent early termination and subsequent small sample size of the study. Novel techniques for prevention and therapy of POPF should be evaluated in future trials.

SUBMITTER: Huttner FJ

PROVIDER: S-EPMC6191135 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

2-octyl cyanoacrylate sealing of the pancreatic remnant after distal pancreatectomy - A prospective pilot study.

Hüttner Felix J FJ Probst Pascal P Kenngott Hannes G HG Knebel Phillip P Hackert Thilo T Ulrich Alexis A Büchler Markus W MW Diener Markus K MK

PloS one 20181016 10

<h4>Background</h4>Postoperative pancreatic fistula (POPF) remains a frequent problem especially after distal pancreatectomy. The application of 2-octyl cyanoacrylate showed promising results in the reduction of POPF after pancreatoduodenectomy prompting an expansion of this technique to distal pancreatectomy. Thus, the objective of the current study was to assess safety, feasibility and preliminary efficacy of an intraoperative 2-octyl cyanoacrylate application after distal pancreatectomy.<h4>M ...[more]

PMID: 30325942

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Project description:BackgroundTo evaluate the efficacy and safety of a modified pancreatic remnant-gastric coverage technique in laparoscopic distal pancreatectomy (LDP).MethodsThis retrospective study analyzed clinical data from 63 patients who underwent LDP between March 2017 and April 2024 at the Hepatobiliary and Pancreatic Surgery Department, The Affiliated LiHuiLi Hospital of Ningbo University. Patients were divided into two groups based on the pancreatic remnant management method: the experimental group (n = 28) underwent pancreatic remnant-gastric coverage, while the control group (n = 35) had the pancreatic remnant closed using a stapler followed by hand-sewn reinforcement. The parameters observed included general patient characteristics, intraoperative data, and postoperative data. We compared and analyzed all the above data between the two groups of patients both before and after propensity score matching (PSM).ResultsAll 63 patients were successfully operated. Before PSM, the incidence of POPF (Grade B/C) in the experimental group was significantly lower than in the control group (14.3% vs 34.3%, P < 0.05). And the incidence of POPF (BL) in the experimental group was lower than in the control group (39.3% vs 51.4%). After PSM, the difference in the incidence of POPF (Grade B/C) between the two groups remained statistically significant (16.0% vs 32.0%, P < 0.05). The incidence of POPF (BL) in the experimental group was also lower than in the control group (36.0% vs 56.0%). There were no statistically significant differences between the two groups in terms of operation time, pancreatic texture, thickness of pancreatic stump, intraoperative bleeding, intraoperative transfusion, post-pancreatectomy hemorrhage, abdominal infection, encapsulated effusion, or delayed gastric emptying both before and after PSM (P > 0.05).ConclusionThe use of the modified pancreatic remnant-gastric coverage in LDP effectively reduces the incidence of POPF and is both safe and feasible, making it a technique worth promoting.

Project description:ImportanceUnderstanding the learning curve of a new complex surgical technique helps to reduce potential patient harm. Current series on the learning curve of minimally invasive distal pancreatectomy (MIDP) are mostly small, single-center series, thus providing limited data.ObjectiveTo evaluate the length of pooled learning curves of MIDP in experienced centers.Design, setting, and participantsThis international, multicenter, retrospective cohort study included MIDP procedures performed from January 1, 2006, through June 30, 2019, in 26 European centers from 8 countries that each performed more than 15 distal pancreatectomies annually, with an overall experience exceeding 50 MIDP procedures. Consecutive patients who underwent elective laparoscopic or robotic distal pancreatectomy for all indications were included. Data were analyzed between September 1, 2021, and May 1, 2022.ExposuresThe learning curve for MIDP was estimated by pooling data from all centers.Main outcomes and measuresThe learning curve was assessed for the primary textbook outcome (TBO), which is a composite measure that reflects optimal outcome, and for surgical mastery. Generalized additive models and a 2-piece linear model with a break point were used to estimate the learning curve length of MIDP. Case mix-expected probabilities were plotted and compared with observed outcomes to assess the association of changing case mix with outcomes. The learning curve also was assessed for the secondary outcomes of operation time, intraoperative blood loss, conversion to open rate, and postoperative pancreatic fistula grade B/C.ResultsFrom a total of 2610 MIDP procedures, the learning curve analysis was conducted on 2041 procedures (mean [SD] patient age, 58 [15.3] years; among 2040 with reported sex, 1249 were female [61.2%] and 791 male [38.8%]). The 2-piece model showed an increase and eventually a break point for TBO at 85 procedures (95% CI, 13-157 procedures), with a plateau TBO rate at 70%. The learning-associated loss of TBO rate was estimated at 3.3%. For conversion, a break point was estimated at 40 procedures (95% CI, 11-68 procedures); for operation time, at 56 procedures (95% CI, 35-77 procedures); and for intraoperative blood loss, at 71 procedures (95% CI, 28-114 procedures). For postoperative pancreatic fistula, no break point could be estimated.Conclusion and relevanceIn experienced international centers, the learning curve length of MIDP for TBO was considerable with 85 procedures. These findings suggest that although learning curves for conversion, operation time, and intraoperative blood loss are completed earlier, extensive experience may be needed to master the learning curve of MIDP.

Dataset Information

2-octyl cyanoacrylate sealing of the pancreatic remnant after distal pancreatectomy - A prospective pilot study.

Background

Methods

Results

Conclusions

Publications

2-octyl cyanoacrylate sealing of the pancreatic remnant after distal pancreatectomy - A prospective pilot study.

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