Laparoscopic Versus Open Distal Pancreatectomy for Pancreatic Cancer: a Multicenter Randomized Controlled Trial

Seoul National University

Status: Enrolling

Conditions: Pancreas Neoplasm Malignant Resectable

Treatments: Procedure: Laparoscopic distal pancreatectomy; Procedure: open distal pancreatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03957135

SNUBH-GS-HBP4

Details and patient eligibility

About

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.

Full 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

Enrollment: 244 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

244 participants in 2 patient groups

Laparoscopic distal pancreatectomy

Experimental group

Description:

Patients receiving laparoscopic distal pancreatectomy for pancreatic tail and body cancer

Treatment:

Procedure: Laparoscopic distal pancreatectomy

open distal pancreatectomy

Active Comparator group

Description:

Patients receiving open distal pancreatectomy for pancreatic tail and body cancer

Treatment:

Procedure: open distal pancreatectomy