Comparison of Functional Recovery Between Laparoscopic and Open Pancreaticoduodenectomy

NCT03870698 | Completed DMC

• 1 other identifier: CORLAPPD_01
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic surgery has not changed much in safety compared with open surgery through many existing studies, and has become a procedure to help patients' recovery. Recently, laparoscopic surgery has been actively performed for pancreaticoduodenectomy, one of the most complicated procedures in intraperitoneal surgery. the investigators will perform a prospective study to establish a higher level of evidence for the efficacy and safety of laparoscopic pancreaticoduodenectomy. The purpose of this study was to compare the short-term clinical outcomes including the functional recovery after surgery, complications and confirm that laparoscopic pancreaticoduodenectomy is safe and appropriate. This study includes an interim analysis and can be terminated early by analysis at the completion of 50% of planned patients.

Conditions

Functional Recovery; Laparoscopy; Periampullary Cancer

Outcome Measures

Primary Outcomes (1)

• Time to functional recovery after surgery

  It is defined that functional recovery is achieved if all of the following are satisfied. 1\. Pain can be controlled by oral or patch analgesic without intravenous analgesics. \* 2. Free walking (modified enhanced recovery after surgery mobility scale 5/5) \*\* 3. Free diet is available (more than 1/2 of the dietary intake) 4. No evidence of infection (body temperature \<38.5 degrees, C-reactive protein (CRP) 15 mg / dL, no complicated fluid collection on postoperative computed tomography 5. There should be no intravenous injection .

  up to 1 months

Secondary Outcomes (7)

• Numbers of Hospital stay

  up to 2 months

• Minutes of operation time

  Up to 1 day after surgery

• amount of estimated blood loss

  up to 1 day after surgery

• Severity of postoperative pain

  Up to 3 days

• postoperative complications

  up to 2 months

Study Arms (2)

Laparoscopic group

EXPERIMENTAL

The patients who underwent laparoscopic procedures for periampullary tumors

Procedure: Laparoscopic group

Open group

NO INTERVENTION

The patients who underwent open procedures for periampullary tumors

Interventions

Laparoscopic group PROCEDURE

The patients in laparoscopic group will underwent pylorus preserving pancreaticoduodenectomy in laparoscopic manners.

Laparoscopic group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 19 to 80 years
• Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
• The preoperative examination showed that the lesion could not be invaded by major blood vessels.
• No distant metastasis
• Bone marrow function: white blood cell (WBC) at least 3,000 / mm3, Platelet count at least 100,000 / mm3
• Kidney function: Creatinine no greater than 1.5 times upper limit of normal.
• Patients who consented to and signed the consent

You may not qualify if:

• Severe obesity (BMI\> 30)
• Those with active or uncontrolled infections
• Those with severe psychiatric / neurological disorders
• Alcohol or other drug addicts
• Patients included in other clinical studies that may affect this study
• Patients who cannot follow the directions of the researcher
• Those with uncontrolled heart disease
• Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (cirrhosis, chronic kidney failure, heart failure, etc.)
• Pelvic tumor, benign tumor, malignant tumor in other organs
• Patients who received prior chemotherapy
• In addition to the planned PD patients who require resection of other major abdominal organs (such as gastrectomy, colonic resection and portal / upper mesenteric vascular resection, more than standard PD)

Sponsors & Collaborators

• Asan Medical Center: lead
• Seoul National University Bundang Hospital: collaborator
• Severance Hospital: collaborator
• Samsung Medical Center: collaborator
• Hallym University Medical Center: collaborator

Study Sites (1)

Asan medical center

Seoul, 05505, South Korea

Location

Related Publications (1)

• Yoon YS, Lee W, Kang CM, Hong T, Shin SH, Lee JW, Hwang DW, Song KB, Kwon JW, Sung MK, Shim IK, Lee JB, Kim SC; for Korean Study Group on Minimally Invasive Pancreatic Surgery (K-MIPS). Laparoscopic versus open pancreatoduodenectomy for periampullary tumors: a randomized clinical trial. Int J Surg. 2024 Nov 1;110(11):7011-7019. doi: 10.1097/JS9.0000000000002035.

  PMID: 39172725 DERIVED

Study Officials

• Song-Cheol Kim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 12, 2019
• Study Start: May 9, 2019
• Primary Completion: June 10, 2022
• Study Completion: August 31, 2022
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)