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• W4385575204 abstract "Pancreatic Cancer: Pancreatic CancerA minimally invasive approach to surgically remove tumors during early-stage operable pancreatic cancer is just as safe and effective as traditional open surgery, according to results from an international Phase III DIPLOMA randomized trial. The approach, either laparoscopic or robotic surgery, removes tumors from the body or distal tail of the pancreas, along with the spleen, using smaller incisions that generally result in fewer complications compared to one large incision used in open surgery. “With this trial, which is the first trial of its kind, I can confirm that minimally invasive distal pancreatectomy (MIDP) is a safe, valid, efficient alternative approach to the open approach in the treatment of resectable pancreatic cancer in the body or tail of the pancreas,” said Mohammad Abu Hillel, MD, PhD, Surgical Director of the Instituto Ospedaliero Fondazione Poliambulanza in Brescia, Italy, who presented findings during 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Jennifer F. Tseng, MD, MPH, Chair of the Department of Surgery at the Boston University School of Medicine and ASCO's designated expert, added, “This randomized surgical trial will help both surgeons and patients feel comfortable that minimally invasive surgery, in expert hands, is not inferior to open surgery. This may provide benefits like faster recovery time and less infection risk without increasing cancer risk.” In 2023, about 64,050 adults in the U.S. will be diagnosed with pancreatic cancer and only 12 percent of them will be diagnosed at an early stage when surgical removal of the tumor is possible. The 5-year relative survival rate for early-stage pancreatic cancer treated with surgery is 44 percent. Pancreatic resections are considered to be among the most technically demanding surgical procedures that include a high risk of potentially life-threatening complications and outcomes strongly associated with hospital patient volume and the experience of individual surgeons. Over the past decade or so, minimally invasive pancreatic resections have become standard surgical practice worldwide, largely in high-volume centers with highly trained and experienced surgeons and medical staff. However, its overall adoption into clinical practice has been slow compared to other surgical procedures, largely due to conflicting results—reported in low-volume centers—showing high conversion rates to open surgery, inferior oncological outcomes, and increased mortality. In 2015, about one-third of pancreatic cancer surgeons surveyed raised concerns about the safety and efficacy of the minimally invasive approach compared to open surgery. “Hence, a need to answer the question about the validity of the minimally invasive approach as an alternative approach to the traditional open surgical approach was becoming more and more a hot topic of discussion in many surgical forums,” Hillel said during ASCO. Minimally Invasive Approach To help resolve these concerns, the international Phase III DIPLOMA randomized study was designed to establish if the minimally invasive approach was non-inferior or no worse than the established open-surgery technique. “The randomized controlled trials are always the last step to convince people who are not convinced or to support people who are convinced of doing it to have some codification for what they're doing and some strong evidence to increase that practice in the field,” Hillel said. Between May 8, 2018, and May 7, 2021, 258 patients from 35 centers in 12 countries were randomly assigned 1:1 to minimally invasive surgery or open surgery in the DIPLOMA trial. Eligible patients included adults with operable tumors in the tail or body or the pancreas; those with borderline resectable disease were excluded. The modified intention-to-treat population resulted in 117 patients included in the MIDP group, with 114 in the open-surgery cohort. Patients, pathologists, and nurses in the surgical theatre were all blinded to the assigned approach through coverings over the abdominal cavity or abdominal wall. Patients were closely followed postoperatively from 2 weeks to 12 months when a CT was performed. The primary endpoint was R0 radical resection, a microscopically margin-negative resection in which no gross or microscopic tumor remains in the primary tumor bed. Hillel acknowledged that survival would have been a better primary endpoint, but many thousands of patients would be needed for such a study. Other studies have demonstrated that R0 would be a suitable surrogate marker that's “very closely” associated with survival. Study Results Results from the DIPLOMA study showed that radical resection or complete removal of the tumor with some healthy surrounding tissue was achieved in 73 percent of the patients (83 patients) who underwent MIDP compared to 69 percent (76 patients) who had open surgery. Lymph node yields were comparable with both approaches with a median of 22 nodes removed in the minimally invasive group and 23 in the open-surgery cohort. The trial also found no significant difference for intraperitoneal recurrence, with 41 percent among the MIDP group compared to 38 percent in the open-surgery cohort. Adverse events—including bleeding and injuries to other organs or conversion from laparoscopy to open surgery—were similar in both approaches (18% for MIDP vs. 22% with open surgery). Though not powered by survival, overall survival outcomes were virtually the same for both groups—overall survival of 40 months for the MIDP group and 39 months for open surgery. Likewise, disease-free survival was nearly identical in both groups, 44 months for the MIDP cohort and 45 months for those in the open-surgery group. The benefit of shorter time to functional recovery, about 5 days in each arm, could not be confirmed by this study. “This could be for different reasons—the entity of the disease, but also it is possible due to differences in the social sanitary management of patients in different countries which have been involved,” Hillel said. When asked how much training was required before surgeons should attempt this minimally invasive approach to resectable pancreatic cancer, Hillel said: “The surgeon who will be performing [this] should be well-trained in open surgery, but also well-trained in minimally invasive surgery. Patients should be sent to specialized centers in this field where the surgeon can develop experience, but also the team, because it's not all about the surgeon. It's about the anesthetist, the theatre nurse, but also about the pathologist who examines the specimen and the oncologist who will treat the patient before and after.” Hillel and team said they will continue to follow these patients to compare their outcomes at 3 years and 5 years. Additional analysis of samples retrieved during this study will look at the number of lymph nodes removed in the spleen to determine if removing the spleen is necessary. Additional trials also will be conducted to compare outcomes between the laparoscopic and robotic minimally invasive surgical techniques. Warren Froelich is a contributing writer." @default.
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• W4385575204 date "2023-08-05" @default.
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• W4385575204 title "A Minimally Invasive Approach for Tumor Removal in Pancreatic Cancer" @default.
• W4385575204 doi "https://doi.org/10.1097/01.cot.0000947660.31146.7a" @default.
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