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

September 17, 2022 updated by: Ho-Seong Han, Seoul National University Hospital

Multicenter Prospective Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Distal Pancreatectomy for Ductal Adenocarcinoma of the Pancreatic Body and Tail

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Kyeonggi-do
      • Seongnam-si, Kyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Ho-Seong Han, M.D.,Ph.D.
        • Sub-Investigator:
          • Yoo-Seok Yoon, M.D.,Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laparoscopic distal pancreatectomy
Patients receiving laparoscopic distal pancreatectomy for pancreatic tail and body cancer
Procedure: Laparoscopic distal pancreatectomy
Laparoscopic resection of the diseased portion of the pancreas for treatment of pancreatic cancer
ACTIVE_COMPARATOR: open distal pancreatectomy
Patients receiving open distal pancreatectomy for pancreatic tail and body cancer
Procedure: open distal pancreatectomy
Open resection of the diseased portion of the pancreas for treatment of pancreatic cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 year survival
Time Frame: 2 years
Overall survival at 2 years after surgery
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Samsung Medical Center
Seoul St. Mary's Hospital
Asan Medical Center
Seoul National University Bundang Hospital
Gangnam Severance Hospital
Severance Hospital

Investigators

  • Principal Investigator: Ho-Seong Han, M.D. Ph.D., Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 20, 2019

Primary Completion (ANTICIPATED)

November 30, 2025

Study Completion (ANTICIPATED)

November 30, 2025

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (ACTUAL)

May 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 17, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-GS-HBP4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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