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Trial record 39 of 131 for:    Pancreatic Cancer | ( Map: South Korea )

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

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ClinicalTrials.gov Identifier: NCT03957135
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Severance Hospital
Asan Medical Center
Seoul St. Mary's Hospital
Information provided by (Responsible Party):
Ho-Seong Han, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreas Neoplasm Malignant Resectable Procedure: Laparoscopic distal pancreatectomy Procedure: open distal pancreatectomy Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Prospective Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Distal Pancreatectomy for Ductal Adenocarcinoma of the Pancreatic Body and Tail
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : November 30, 2025
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 2 year survival [ Time Frame: 2 years ]
    Overall survival at 2 years after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features
  • No evidence of distant metastasis
  • No direct invasion of adjacent structures, with the exception of mesocolon or left adrenal gland
  • Possible to achieve a negative margin from adjacent major vasculature (Common hepatic artery, superior mesenteric artery, celiac axis, superior mesenteric vein - portal vein)
  • Eastern Cooperative Oncology Group (ECOG) performance score 0-2
  • Patients with informed consent

Exclusion Criteria:

  • History of other malignancy (with the exception of more than 5 year interval, with no evidence of recurrence)
  • Necessity of resection of other abdominal organs
  • Recurrent pancreatic cancer
  • Neoadjuvant chemotherapy
  • Comorbidities with a high risk for general anesthesia
  • Other subject whom the investigator deems inappropriate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957135


Contacts
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Contact: Jun Suh Lee, M.D. Ph.D. +82-10-2747-6320 rudestock@gmail.com
Contact: Yoo-Seok Yoon, M.D. Ph.D. arsyun@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Kyeonggi-do, Korea, Republic of, 13620
Contact: Jun Suh Lee, M.D., Ph.D.    +82-10-2747-6320    rudestock@gmail.com   
Principal Investigator: Ho-Seong Han, M.D.,Ph.D.         
Sub-Investigator: Yoo-Seok Yoon, M.D.,Ph.D.         
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Severance Hospital
Asan Medical Center
Seoul St. Mary's Hospital
Investigators
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Principal Investigator: Ho-Seong Han, M.D. Ph.D. Seoul National University Bundang Hospital

Publications:
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Responsible Party: Ho-Seong Han, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03957135     History of Changes
Other Study ID Numbers: SNUBH-GS-HBP4
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ho-Seong Han, Seoul National University Hospital:
pancreas neoplasms
pancreatectomy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gastrointestinal Agents