Trial ID: ISRCTN27483786
Other - Phase Unknown - No longer available
Background and study aims For patients with a (pre-)malignant pancreatic or periampullary (head of the pancreas) tumor, a pancreatoduodenectomy (surgery to remove the head of the pancreas, duodenum, gallbladder and other nearby tissues) is the only treatment with curative intent. A pancreatoduodenectomy is a complex operation with high technical difficulty and challenging postoperative management. Despite major improvements in the last decade, pancreatoduodenctomy remains associated with considerable perioperative morbidity (illness around the time of surgery), strongly impacting the patient’s quality of life and healthcare resources. Minimally invasive pancreatoduodenectomy (MIPD), both robot-assisted and laparoscopic (keyhole surgery), has gained popularity in the last decade and reduces surgical trauma as compared to open pancreatoduodenectomy (OPD), aiming for faster recovery and improved outcomes. However, MIPD is associated with higher costs and a longer learning curve, and there have been conflicting results with regard to postoperative complications compared to OPD. As MIPD is increasingly being used in clinical practice worldwide, a randomized controlled trial (RCT) comparing MIPD to the open approach is needed to demonstrate that MIPD offers improved outcomes that justify the high cost, longer operative times, and steep learning curve. Therefore, the aim of this study is to compare the outcomes of MIPD (both robotic and laparoscopic) with OPD for premalignant and malignant disease. The study is designed to primarily investigate the safety of MIPD (both robotic and laparoscopic) in terms of morbidity (illness) and mortality (death), and furthermore to assess if MIPD is superior to OPD in terms of time to functional recovery. Who can participate? Patients aged over 18 years who require pancreatoduodenectomy for resection of premalignant or malignant disease. What does the study involve? Participants are randomly allocated to either minimally invasive or open surgery. After surgery, patients receive a large abdominal dressing to mask their treatment by covering all incisions. This abdominal dressing is removed when recovery is complete on day 5 after the operation or for medical reasons, such as suspicion of a wound infection. Participants will be asked to wear a Fitbit™ Inspire 2 watch from before surgery up to 90 days after surgery. Participants complete quality of life questionnaires before surgery and at 1, 3 and 6 months after surgery. Survival rates are calculated for 1 and 3 years after the surgery. What are the possible benefits and risks of participating? Minimally invasive surgery may reduce the time to functional recovery, length of hospital stay and improve short-term quality of life, with similar postoperative morbidity rates. All centers have experience of more than 60 minimally invasive procedures before the study. There are no added risks. Where is the study run from? 1. Amsterdam UMC (Netherlands) 2. Fondazione Poliambulanza Istituto Ospedaliero (Italy) When is the study starting and how long is it expected to run for? July 2020 to December 2026 Who is funding the study? 1. Amsterdam UMC (Netherlands) 2. Fondazione Poliambulanza Istituto Ospedaliero (Italy) 3. Intuitive Surgical Inc. (USA) Who is the main contact? 1. Prof. Marc G. Besselink, m.g.besselink@amsterdamumc.nl 2. Prof. Mohammed Abu Hilal, abuhilal9@gmail.com For DIPLOMA-2x2: Background and study aims For patients with a cancer in the pancreatic head (pancreatic ductal adenocarcinoma [PDAC] and distal cholangiocarcinoma [DCC]), a pancreatoduodenectomy (surgery to remove the head of the pancreas, duodenum, gallbladder and other nearby tissues) is the only treatment with curative intent. A pancreatoduodenectomy is a complex operation with high technical difficulty and challenging postoperative management. Despite major improvements in the last decade, pancreatoduodenctomy remains associated with considerable perioperative morbidity (illness around the time of surgery), strongly impacting the patient’s quality of life and healthcare resources. Robot-assisted pancreatoduodenectomy (RPD) has gained popularity in the last decade. The safety of the robotic approach has recently been confirmed with comparable postoperative complications and enhanced postoperative recovery compared to open pancreatoduodenectomy (OPD). However, studies in gynecology and colorectal surgery showed that minimally invasive surgery was inferior in terms of radicality in patients with malignant disease. Hence, the oncological safety of RPD as compared to OPD remains to be determined. Therefore, the aim of this study is to compare the oncological outcome of RPD with OPD for cancer in the pancreatic head (PDAC and DCC). The study is designed to primarily investigate the radicality (R0 resection rate), and furthermore to assess if RPD is superior to OPD in terms of time to functional recovery in patients with cancer in the pancreatic head. Who can participate? Patients aged over 18 years who require pancreatoduodenectomy for resection of PDAC or DCC. What does the study involve? Participants are randomly allocated to either robot-assisted or open surgery. After surgery, patients receive a large abdominal dressing to mask their treatment by covering all incisions. This abdominal dressing is removed when recovery is complete on day 5 after the operation or for medical reasons, such as suspicion of a wound infection. Participants complete quality of life questionnaires before surgery and at 1, 3, 6 months and 1, 3, and 5 years after surgery. Survival rates are calculated for 1, 3, and 5 years after the surgery. What are the possible benefits and risks of participating? Robot-assisted surgery may reduce the time to functional recovery, length of hospital stay, and the time to start adjuvant therapy, with similar postoperative morbidity rates. All centers have experience of more than 60 minimally invasive procedures before the study. There are no added risks. Where is the study run from? Amsterdam UMC (Netherlands) When is the study starting and how long is it expected to run for? December 2023 to February 2026 Who is funding the study? 1. Amsterdam UMC (Netherlands) 2. Intuitive Surgical Inc. (USA) 3. Dutch Cancer Society (KWF) Who is the main contact? 1. Prof. Marc G. Besselink, m.g.besselink@amsterdamumc.nl 2. Prof. Mohammed Abu Hilal, abuhilal9@gmail.com
Amsterdam University Medical Centers, Fondazione Poliambulanza Istituto Ospedaliero
Source: https://www.isrctn.com/