Health
Minimally invasive distal pancreatectomy offers an effective alternative for resectable pancreatic cancer
Minimally invasive distal pancreatic resection (MIDP) has been found to be a safe and effective alternative to open distal pancreatic resection (ODP) for patients with resectable pancreatic cancer, with a non-inferior curative Results from the first-of-its-kind DIPLOMA study (ISRCTN44897265), presented at a press conference ahead of the 2023 ASCO Annual Meeting, said to be confirmed by resection rate, lymph node yield, and comparable survival data.
The R0 resection rate was 73% with MIDP and 69% with ODP (P. = .039), confirming the non-inferiority of MIDP. Furthermore, no substantial difference was found in the yield of lymph nodes from the two approaches, which were 22 and 23 respectively (P. = .89). Moreover, the time to functional recovery was “similar between the two groups,” at 5 days in each group, said lead author Mohammad Abu Hilal, M.D., Ph.D.P. = .22).
“The OS vs. disease-free survival curve [DFS, in both arms] Almost overlapping, almost identical,” Hilal reported. “From what I can remember, our median OS is 40 months for him. [MIDP] and for 36 months [ODP]. DFS was 44 and 45 months. [respectively.] Is the same, [almost] that’s right, [for] Two approaches. “
Hilal said the use of MIDP has increased since 1994. The benefits of this procedure are associated with time to functional recovery and length of hospital stay, but there are concerns regarding lymph node yield, curability, and survival outcomes. A recent hysterectomy trial showed inferior outcomes with minimally invasive surgical approaches, highlighting the need to consider this approach compared to ODP.
The trial had a non-inferiority design with a margin of -7%. Patients were randomly assigned 1:1 to her MIDP or ODP, and both pathologist and patient were blinded by abdominal dressing.
“This is a very powerfully designed study from many angles,” Hilal explained. “The first is the standardization of surgical techniques. [and the] The second is the standardization of pathology examinations among all participating pathologists and all surgeons, as well as the blinding of abdominal cavity or abdominal wall coverings, especially for patients, ward nurses, and pathologists. It’s the side. “
Follow-up was performed after surgery, 2 weeks, 1, 3, 6 and 12 months. A CT scan was then performed at 12 months. Hilal said the researchers also collected patient feedback on the quality of care.
The primary endpoint was radical resection (R0, distance between tumor and margin ≥1 mm). “We know that survival was the best primary endpoint, but that requires thousands of patients. [would be] We need it,” Hilal said. “Therefore, R0 resection was chosen, which has been shown to be closely associated with survival in various studies.”
258 patients were enrolled in this study at 35 centers in 12 countries. Of these patients, 131 were assigned to his MIDP group and 127 to his ODP group.
Serious side effects occurred in 18% and 22% of patients receiving MIDP or ODP, respectively.
“This study did not confirm the benefits of shorter hospital stays and functional recovery,” Hilal said. “There could be many reasons for this, not only the nature of the disease, but also differences in social hygiene management of patients in the countries involved.”
reference
Correll M, Jones L, Hirst JV, et al Minimally invasive distal pancreatectomy (DIPLOMA) for resectable pancreatic cancer: an international randomized trial. J Clin Ongol. 2023;41(suppl 16):4163. doi:10.1200/JCO.2023.41.16_suppl.5500
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