Minimally-invasive distal pancreatectomy with splenectomy is a safe and effective alternative to traditional open surgery for patients with resectable pancreatic cancer, according to results from DIPLOMA, according to an international randomised phase 3 trial presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
This surgical approach offers a lower risk of serious complications compared to open surgery.
DIPLOMA is the first randomised, patient-blinded study to compare outcomes between open surgery and minimally-invasive surgery for patients with early-stage pancreatic cancer when tumours are present on the body or tail of the pancreas. Between May 2018 and May 2021, the DIPLOMA trial enrolled 258 patients with resectable pancreatic cancer from 35 centres in 12 countries. Of those, 231 continued with the trial and were randomly assigned to either the intervention group, receiving minimally-invasive distal pancreatectomy, or the control group, receiving standard open surgery. Some 117 patients received minimally-invasive surgery, either laparoscopic or robot-assisted, and 114 patients received open surgery.
Radical resection occurred in 83 patients (73 per cent) in the minimally-invasive group and in 76 patients (69 per cent) in the open surgery group.
After surgery, researchers also found the number of lymph nodes removed during surgery was 22 in the minimally-invasive group and 23 in the open surgery group. The minimum lymph node yield for a successful distal pancreatectomy is 13 lymph nodes.
Results wise, the intraperitoneal recurrence was 41 per cent in the minimally-invasive group and 38 per cent in the open surgery group.
“This confirmatory study proves that minimally-invasive surgical techniques are a safe and effective option for resectable pancreatic cancer. This randomised 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,” said Dr Jennifer F Tseng, ASCO expert.
Researchers will continue to follow these patients to compare their outcomes at three years and five years and additional analysis of the 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.
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