Randomized clinical trial of laparoscopic versus open pancreatoduodenectomy for periampullary tumours
TL;DR: The aim of this study was to compare laparoscopic and open pancreatoduodenectomy for short‐term outcomes in a randomized trial.
Abstract: Background
Laparoscopic resection as an alternative to open pancreatoduodenectomy may yield short-term benefits, but has not been investigated in a randomized trial. The aim of this study was to compare laparoscopic and open pancreatoduodenectomy for short-term outcomes in a randomized trial.
Methods
Patients with periampullary cancers were randomized to either laparoscopic or open pancreatoduodenectomy. The outcomes evaluated were hospital stay (primary outcome), and blood loss, radicality of surgery, duration of operation and complication rate (secondary outcomes).
Results
Of 268 patients, 64 who met the eligibility criteria were randomized, 32 to each group. The median duration of postoperative hospital stay was longer for open pancreaticoduodenectomy than for laparoscopy (13 (range 6–30) versus 7 (5–52) days respectively; P = 0·001). Duration of operation was longer in the laparoscopy group. Blood loss was significantly greater in the open group (mean(s.d.) 401(46) versus 250(22) ml; P < 0·001). Number of nodes retrieved and R0 rate were similar in the two groups. There was no difference between the open and laparoscopic groups in delayed gastric emptying (7 of 32 versus 5 of 32), pancreatic fistula (6 of 32 versus 5 of 32) or postpancreatectomy haemorrhage (4 of 32 versus 3 of 32). Overall complications (defined according to the Clavien–Dindo classification) were similar (10 of 32 versus 8 of 32). There was one death in each group.
Conclusion
Laparoscopy offered a shorter hospital stay than open pancreatoduodenectomy in this randomized trial. Registration number: NCT02081131( http://www.clinicaltrials.gov).
Citations
More filters
TL;DR: This multicentre, patient-blinded, parallel-group, randomised controlled phase 2/3 trial was performed in four centres in the Netherlands to assess whether laparoscopic pancreatoduodenectomy could reduce time to functional recovery compared with open pancreatic fistula.
339 citations
TL;DR: In patients with left-sided pancreatic tumors confined to the pancreas, MIDP reduces time to functional recovery compared with ODP and was associated with less delayed gastric emptying and better quality of life without increasing costs.
Abstract: OBJECTIVE: This trial followed a structured nationwide training program in minimally invasive distal pancreatectomy (MIDP), according to the IDEAL framework for surgical innovation, and aimed to compare time to functional recovery after minimally invasive and open distal pancreatectomy (ODP). BACKGROUND: MIDP is increasingly used and may enhance postoperative recovery as compared with ODP, but randomized studies are lacking. METHODS: A multicenter patient-blinded randomized controlled superiority trial was performed in 14 centers between April 2015 and March 2017. Adult patients with left-sided pancreatic tumors confined to the pancreas without vascular involvement were randomly assigned (1:1) to undergo MIDP or ODP. Patients were blinded for type of surgery using a large abdominal dressing. The primary endpoint was time to functional recovery. Analysis was by intention to treat. This trial was registered with the Netherlands Trial Register (NTR5689). RESULTS: Time to functional recovery was 4 days [interquartile range (IQR) 3-6) in 51 patients after MIDP versus 6 days (IQR 5-8) in 57 patients after ODP (P < 0.001). The conversion rate of MIDP was 8%. Operative blood loss was less after MIDP (150 vs 400 mL; P < 0.001), whereas operative time was longer (217 vs 179 minutes; P = 0.005). The Clavien-Dindo grade ≥III complication rate was 25% versus 38% (P = 0.21). Delayed gastric emptying grade B/C was seen less often after MIDP (6% vs 20%; P = 0.04). Postoperative pancreatic fistulas grade B/C were seen in 39% after MIDP versus 23% after ODP (P = 0.07), without difference in percutaneous catheter drainage (22% vs 20%; P = 0.77). Quality of life (day 3-30) was better after MIDP as compared with ODP, and overall costs were non-significantly less after MIDP. No 90-day mortality was seen after MIDP versus 2% (n = 1) after ODP. CONCLUSIONS: In patients with left-sided pancreatic tumors confined to the pancreas, MIDP reduces time to functional recovery compared with ODP. Although the overall rate of complications was not reduced, MIDP was associated with less delayed gastric emptying and better quality of life without increasing costs.
330 citations
TL;DR: In this paper, perioperative outcomes of pancreatoduodenectomy (PD) performed through the laparoscopic route or by open surgery were compared in a single-center RCT.
Abstract: Objective:To compare perioperative outcomes of pancreatoduodenectomy (PD) performed through the laparoscopic route or by open surgery.Summary Background Data:Laparoscopic PD is being progressively performed in selected patients.Methods:An open-label single-center RCT was conducted between February 2
216 citations
TL;DR: At current level of evidence, LPD shows no advantage over OPD and further studies should focus on patient safety during LPD learning curves and the potential role of robotic surgery.
Abstract: Objective:To compare perioperative outcomes of laparoscopic pancreaticoduodenectomy (LPD) to open pancreaticoduodenectomy (OPD) using evidence from randomized controlled trials (RCTs).Background:LPD is used more commonly, but this surge is mostly based on observational data.Methods:We searched CENTR
177 citations
TL;DR: Uniform guidelines for diagnosis, treatment and follow-up of pancreatic cysts are urgently required and evidence on the best surveillance interval is lacking.
Abstract: Pancreatic cystic neoplasms (PCN) are a heterogeneous group of pancreatic cysts that include intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions, all with different biological behaviours and variable risk of progression to malignancy. As more pancreatic cysts are incidentally discovered on routine cross-sectional imaging, optimal surveillance for patients with PCN is becoming an increasingly common clinical problem, highlighting the need to balance cancer prevention with the risk of (surgical) overtreatment. This Review summarizes the latest developments in the diagnosis and management of PCN, including the quality of available evidence. Also discussed are the most important differences between the PCN guidelines from the American Gastroenterological Association, the International Association of Pancreatology and the European Study Group on Cystic Tumours of the Pancreas, including diagnostic and follow-up strategies and indications for surgery. Finally, new developments in the management of patients with PCN are addressed.
129 citations
References
More filters
TL;DR: The new complication classification appears reliable and may represent a compelling tool for quality assessment in surgery in all parts of the world.
Abstract: Growing demand for health care, rising costs, constrained resources, and evidence of variations in clinical practice have triggered interest in measuring and improving the quality of health care delivery. For a valuable quality assessment, relevant data on outcome must be obtained in a standardized and reproducible manner to allow comparison among different centers, between different therapies and within a center over time.1–3 Objective and reliable outcome data are increasingly requested by patients and payers (government or private insurance) to assess quality and costs of health care. Moreover, health policy makers point out that the availability of comparative data on individual hospital's and physician's performance represents a powerful market force, which may contribute to limit the costs of health care while improving quality.4
Conclusive assessments of surgical procedures remain limited by the lack of consensus on how to define complications and to stratify them by severity.1,5–8 In 1992, we proposed general principles to classify complications of surgery based on a therapy-oriented, 4-level severity grading.1 Subsequently, the severity grading was refined and applied to compare the results of laparoscopic versus open cholecystectomy9 and liver transplantation.10 This classification has also been used by others11–13 and was recently suggested to serve as the basis to assess the outcome of living related liver transplantation in the United States (J. Trotter, personal communication). However, the classification system has not yet been widely used in the surgical literature.
The strength of the previous classification relied on the principle of grading complications based on the therapy used to treat the complication. This approach allows identification of most complications and prevents down-rating of major negative outcomes. This is particularly important in retrospective analyses. However, we felt that modifications were necessary, particularly in grading life-threatening complications and long-term disability due to a complication. We also felt that the duration of the hospital stay can no longer be used as a criterion to grade complications. Although definitions of negative outcomes rely to a large extend on subjective “value” appraisals, the grading system must be tested in a large cohort of patients. Finally, a classification is useful only if widely accepted and applied throughout different countries and surgical cultures. Such a validation was not done with the previous classification.
Therefore, the aim of the current study was 3-fold: first, to propose an improved classification of surgical complications based on our experience gained with the previous classification1; second, to test this classification in a large cohort of patients who underwent general surgery; and third, to assess the reproducibility and acceptability of the classification through an international survey.
23,435 citations
Book•
17 Sep 2013
TL;DR: Purposes and Principles of Cancer Staging and End-Results Reporting are explained.
Abstract: General Information on Cancer Staging and End-Results Reporting.- Purposes and Principles of Cancer Staging.- Cancer Survival Analysis.- Head and Neck.- Lip and Oral Cavity.- Pharynx.- Larynx.- Nasal Cavity and Paranasal Sinuses.- Major Salivary Glands.- Thyroid.- Mucosal Melanoma of the Head and Neck.- Digestive System.- Esophagus and Esophagogastric Junction.- Stomach.- Small Intestine.- Colon and Rectum.- Anus.- Gastrointestinal Stromal Tumor.- Neuroendocrine Tumors.- Liver.- Intrahepatic Bile Ducts.- Gallbladder.- Perihilar Bile Ducts.- Distal Bile Duct.- Ampulla of Vater.- Exocrine and Endocrine Pancreas.- Thorax.- Lung.- Pleural Mesothelioma.- Musculoskeletal Sites.- Bone.- Soft Tissue Sarcoma.- Skin.- Cutaneous Squamous Cell Carcinoma and Other Cutaneous Carcinomas.- Merkel Cell Carcinoma.- Melanoma of the Skin.- Breast.- Breast.- Gynecologic Sites.- Vulva.- Vagina.- Cervix Uteri.- Corpus Uteri.- Ovary and Primary Peritoneal Carcinoma.- Fallopian Tube.- Gestational Trophoblastic Tumors.- Genitourinary Sites.- Penis.- Prostate.- Testis.- Kidney.- Renal Pelvis and Ureter.- Urinary Bladder.- Urethra.- Adrenal.- Ophthalmic Sites.- Carcinoma of the Eyelid.- Carcinoma of the Conjunctiva.- Malignant Melanoma of the Conjunctiva.- Malignant Melanoma of the Uvea.- Retinoblastoma.- Carcinoma of the Lacrimal Gland.- Sarcoma of the Orbit.- Ocular Adnexal Lymphoma.- Central Nervous System.- Brain and Spinal Cord.- Lymphoid Neoplasms.- Lymphoid Neoplasms.
16,806 citations
TL;DR: The Consort 2010 Statement as discussed by the authors has been used worldwide to improve the reporting of randomised controlled trials and has been updated by Schulz et al. in 2010, based on new methodological evidence and accumulating experience.
Abstract: The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.
11,165 citations
TL;DR: The 2010 version of the CONSORT Statement is described, which updates the previous reporting guideline based on new methodological evidence and accumulated experience.
Abstract: Kenneth Schulz and colleagues describe the 2010 version of the CONSORT Statement, which updates the previous reporting guideline based on new methodological evidence and accumulated experience.
5,090 citations
TL;DR: In this article, an international panel of pancreatic surgeons, working in well-known, high-volume centers, reviewed the literature on the topic and worked together to develop a simple, objective, reliable, and easy-to-apply definition of postoperative pancreatic fistula, graded primarily on clinical impact.
3,622 citations