Dataset Information

Comparison of 3 Minimally Invasive Methods Versus Open Distal Pancreatectomy: A Systematic Review and Network Meta-Analysis.

ABSTRACT:

Background

The efficacy and safety of open distal pancreatectomy (DP), laparoscopic DP, robot-assisted laparoscopic DP, and robotic DP have not been established. The authors aimed to comprehensively compare these 4 surgical methods using a network meta-analysis.

Materials and methods

The authors systematically searched MEDLINE, Scopus, Web of Science, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for studies that evaluated at least 2 of the following pancreatectomy techniques: robot-assisted DP, laparoscopic DP, open DP, and robotic DP. The surface under the cumulative ranking curve (SUCRA) was applied to show the probability that each method would be the best for each outcome.

Results

Altogether, 46 trials with 8377 patients were included in this network meta-analysis. Robotic DP showed the highest probability of having the least estimated blood loss (SUCRA, 90.9%), the lowest incidences of postoperative pancreatic fistula (SUCRA, 94.5%), clinically related postoperative pancreatic fistula (SUCRA, 94.6%), postoperative bleeding (SUCRA, 75.3%), reoperation (SUCRA, 96.4%), overall complications (SUCRA, 86.9%), and major complications (SUCRA, 99.3%), and the lowest mortality (SUCRA, 83.4%). Robotic DP also proved to be the best approach regarding the attainment of R0 resection (SUCRA, 75.4%) and the number of lymph nodes harvested (SUCRA, 64.1%).

Conclusion

Robotic DP seems to offer clinical and oncological advantages compared with other DP methods for addressing diseases of the pancreatic body and tail, although it may require a longer operation time and learning curve. The present results require confirmation in future head-to-head randomized controlled trials.

SUBMITTER: Lyu Y

PROVIDER: S-EPMC8096312 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundRecently, the first randomized trials comparing minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) for non-malignant and malignant disease showed a 2-day reduction in time to functional recovery after MIDP. However, for pancreatic ductal adenocarcinoma (PDAC), concerns have been raised regarding the oncologic safety (i.e., radical resection, lymph node retrieval, and survival) of MIDP, as compared to ODP. Therefore, a randomized controlled trial comparing MIDP and ODP in PDAC regarding oncological safety is warranted. We hypothesize that the microscopically radical resection (R0) rate is non-inferior for MIDP, as compared to ODP.Methods/designDIPLOMA is an international randomized controlled, patient- and pathologist-blinded, non-inferiority trial performed in 38 pancreatic centers in Europe and the USA. A total of 258 patients with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC of the pancreatic body or tail will be randomly allocated to MIDP (laparoscopic or robot-assisted) or ODP in a 1:1 ratio. The primary outcome is the microscopically radical resection margin (R0, distance tumor to pancreatic transection and posterior margin ≥ 1 mm), which is assessed using a standardized histopathology assessment protocol. The sample size is calculated with the following assumptions: 5% one-sided significance level (α), 80% power (1-β), expected R0 rate in the open group of 58%, expected R0 resection rate in the minimally invasive group of 67%, and a non-inferiority margin of 7%. Secondary outcomes include time to functional recovery, operative outcomes (e.g., blood loss, operative time, and conversion to open surgery), other histopathology findings (e.g., lymph node retrieval, perineural- and lymphovascular invasion), postoperative outcomes (e.g., clinically relevant complications, hospital stay, and administration of adjuvant treatment), time and site of disease recurrence, survival, quality of life, and costs. Follow-up will be performed at the outpatient clinic after 6, 12, 18, 24, and 36 months postoperatively.DiscussionThe DIPLOMA trial is designed to investigate the non-inferiority of MIDP versus ODP regarding the microscopically radical resection rate of PDAC in an international setting.Trial registrationISRCTN registry ISRCTN44897265 . Prospectively registered on 16 April 2018.

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.