ASCO Perspective
“This confirmatory study demonstrates that minimally invasive surgical techniques are a safe and effective option for resectable pancreatic cancer. This randomized surgical trial will help both surgeons and patients feel confident that minimally invasive surgery, in expert hands, is not inferior to open surgery. This may provide benefits such as faster recovery time and less risk of infection, without increasing the risk of cancer,” said Jennifer F. Tseng, MD, an ASCO expert.
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 the DIPLOMA study , an international randomized trial. This surgical approach, which removes tumors located in the body or tail of the pancreas and spleen, uses smaller incisions and offers a lower risk of serious complications compared to open surgery. The research will be presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting.
The study Approach Comparison of Minimally Invasive Distal Pancreatectomy with Open Distal Pancreatectomy for Treating Resectable Pancreatic Cancer Population 258 patients with resectable pancreatic cancer from 35 centers in 12 countries. 117 patients received minimally invasive surgery, either laparoscopic or robot-assisted, and 114 patients received open surgery. Results Radical resection, or complete removal of the tumor with some surrounding healthy tissue, was achieved in 83 patients (73%) who underwent minimally invasive surgery and 76 patients (69%) who underwent open surgery. Lymph node yield was similar in each group, with a median of 22 in the minimally invasive group and 23 in the open surgery group. The intraperitoneal recurrence rate was not significantly different between the two groups: 41% in the minimally invasive group and 38% in the open surgery group. Meaning The study confirms minimally invasive distal pancreatectomy as a valid surgical option for patients with resectable pancreatic cancer. This is the first randomized trial to compare these two surgical techniques for pancreatic cancer, providing reassurance to patients and doctors that the minimally invasive option is safe and effective. |
Key results
DIPLOMA is the first randomized, patient-blinded study comparing outcomes between open surgery and minimally invasive surgery for patients with early-stage pancreatic cancer when tumors are present in the body or tail of the pancreas. Open distal pancreatectomy uses one large incision, while minimally invasive surgery uses several smaller incisions. During this surgery, the spleen is also removed for further lymph node recovery.
This is a non-inferiority trial, which compares an established treatment with another treatment to confirm that the new treatment is no worse than the established standard of care. Both surgical techniques had comparable results. The study’s primary endpoint was radical resection, or complete removal of the tumor and some surrounding healthy tissue.
Radical resection occurred in 83 patients (73%) in the minimally invasive group and in 76 patients (69%) in the open surgery group. After surgery, the researchers also found:
The number of lymph nodes removed during surgery, or the mean lymph node yield, 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.
Intraperitoneal recurrence, or a recurrence of cancer that occurs in the peritoneal cavity, was 41% in the minimally invasive group and 38% in the open surgery group.
“Surgery has made significant advances in the last two decades. One of the most important is the introduction of minimally invasive surgery. For pancreatic cancer, we have shown for the first time that minimally invasive distal pancreatectomy is as good as open surgery. “Our research provides peace of mind to surgeons and can help patients by giving them the information they need to have a conversation with their doctor about how they want to be treated,” said lead author Mohammad Abu Hilal, MD, PhD, Surgical Director of Instituto Ospedaliero. . Fondazione Poliambulanza in Brescia, Italy.
In 2023, an estimated 64,050 adults will be diagnosed with pancreatic cancer in the United States, and only 12% 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 that can be treated with surgery is 44%.
Previous research comparing these two surgical techniques was conducted in the form of systematic reviews and showed a similar outcome between open distal pancreatectomy and minimally invasive pancreatectomy. However, one-third of pancreatic surgeons surveyed have expressed concerns regarding the safety and effectiveness of minimally invasive surgery compared to open surgery. This randomized, blinded trial provides evidence that minimally invasive distal pancreatectomy is a viable option for people with early-stage resectable pancreatic cancer.
About the study
Between May 2018 and May 2021, the international Phase III DIPLOMA trial enrolled 258 patients with resectable pancreatic cancer. Of these, 231 continued with the trial and were randomly assigned to the intervention group, which received minimally invasive distal pancreatectomy, or the control group, which received standard open surgery. Both the patient and the pathologist who examined the samples were unaware of the type of surgery received.
Next steps
The investigators will continue to follow these patients to compare their outcomes at three and five years, and additional analysis of samples recovered during this study will look at the number of lymph nodes removed in the spleen to determine whether the spleen needs to be removed. Researchers will also conduct additional trials to compare outcomes between laparoscopic and robotic minimally invasive surgical techniques.
The study was funded by Medtronic and Ethicon.
