Clinical trial · Interventional
Comparison of Functional Recovery Between Laparoscopic and Open Pancreaticoduodenectomy
Comparison of Perioperative Outcomes Between Laparoscopic and Open Pylorus Preserving Pancreaticoduodenectomy in Periampullary Tumors: Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Functional Recovery | — | UNRESOLVED | — |
| Laparoscopy | — | UNRESOLVED | — |
| Periampullary Cancer | Periampullary Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic group | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic group
- description
- The patients who underwent laparoscopic procedures for periampullary tumors
- interventionNames
- Procedure: Laparoscopic group
- type
- NO_INTERVENTION
- label
- Open group
- description
- The patients who underwent open procedures for periampullary tumors
Primary outcomes (1)
- measure
- Time to functional recovery after surgery
- timeFrame
- up to 1 months
- description
- 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 .
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (1)
- DERIVEDYoon 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