Multicenter Prospective Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Distal Pancreatectomy for Ductal Adenocarcinoma of the Pancreatic Body and Tail
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 244
- Locations
- 1
- Primary Endpoint
- 2 year survival
Overview
Brief Summary
When pancreatic cancer of the body and tail is diagnosed, a distal pancreatectomy is planned. This operation can be performed with open surgery, or with laparoscopic surgery. This study is a multicenter randomized controlled trial to evaluate the operative outcomes and survival of open versus laparoscopic distal pancreatectomy for pancreatic cancer of the body and tail.
Detailed Description
* Purpose
To compare the safety and oncologic feasibility of open versus laparoscopic distal pancreatectomy for the treatment of pancreatic ductal adenocarcinoma (PDAC) of the body and tail.
* Study method
Multicenter prospective randomized controlled trial Noninferiority analysis Patients diagnosed with PDAC of the body and tail, without evidence of distant metastasis or direct invasion of adjacent organs, will be randomly allocated to either the open distal pancreatectomy group or the laparoscopic distal pancreatectomy group. Postoperative outcomes and survival data will be analyzed.
* Number of subjects
Sample size was calculated based on 2 year survival after pancreatectomy.
pA: 2 year survival of open distal pancreatectomy pB: 2 year survival of laparoscopic distal pancreatectomy
Null hypothesis: The 2 year survival of laparoscopic distal pancreatectomy is inferior to that of open distal pancreatectomy. H0: pA-pB≥δ
Alternative hypothesis: The 2 year survival of laparoscopic distal pancreatectomy is not inferior to that of open distal pancreatectomy. H1: pA-pB<δ
2 year survival of pancreatectomy (Shin et al, 2015) is 55.9% for open and 64.3% for laparoscopic distal pancreatectomy.
When α=5%, 1-β=80%, δ=10%, and one-sided analysis is performed with a power of 80%, the required number of subjects is 111 for each group.
With a drop rate of 10%, the final number of each group is 122, with a total of 244.
* Primary and Secondary endpoints
Primary endpoint: 2 year overall survival
Secondary endpoint: R0 resection rate, 2 year disease free survival, 2 year recurrence rate, complication rate, postoperative hospital stay, operative time, estimated blood loss
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- •Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features
- •Patients with resectable pancreatic cancer at the time of surgery (Including borderline resectable pancreatic cancer at the time of diagnosis or Locally advanced pancreatic cancer after chemotherapy or radiation therapy)
- •Lesion (within pancreatic body and tail) is located to the left of the left branch of the hepatic portal vein
- •No remote metastasis in preoperative imaging and not adjacent to the superior mesenteric vein, superior mesenteric artery, and abdominal artery
- •Patients without invasion of adjacent organs other than the left adrenal gland and mesocolon
- •Patients with informed consent
Exclusion Criteria
- •Patients with remote metastasis at the time of diagnosis of pancreatic cancer
- •History of other malignancy (Inclusive if there is no evidence of recurrence after 5 years of treatment)
- •In the case of invasion of other organs other than the left adrenal gland and mesocolon
- •Where major vascular resection, such as the portal vein or abdominal artery, is required to secure negative resection
- •Recurrent pancreatic cancer
- •Patients with underlying diseases at high risk of general anesthesia
- •Preperitoneal or other organ metastases found during surgery
- •In case of previously undergone pancreatic resection
- •Other subject whom the investigator deems inappropriate
Outcomes
Primary Outcomes
2 year survival
Time Frame: 2 years
Overall survival at 2 years after surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Ho-Seong Han
Professor
Seoul National University Hospital