- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06084975
Comparison of Outcomes Between Warshaw and Kimura Techniques for Spleen-preserving Minimally Invasive Distal Pancreatectomy
Comparison of Outcomes Between Warshaw and Kimura Techniques for Spleen-preserving Minimally Invasive Distal Pancreatectomy: With a Specific Focus on Perioperative Patient Safety
Spleen-persevering distal pancreatectomy (SP-DP) has been widely advocated as a routine procedure for benign or low-grade malignant tumors in the pancreatic body and tail, especially with a minimally invasive approach. Spleen preservation can be accomplished with Kimura technique (KT) or Warshaw technique (WT) Both of the two techniques were proved to be feasible and efficient. However, the perioperative outcomes and long-term benefits between patients with KT and WT in spleen-persevering minimally invasive distal pancreatectomy (SP-MIDP) remains controversial.
Several small series have reported a slightly higher prevalence of postpancreatectomy hemorrhage (PPH) in patients who undergo KT than those undergo WT. The exposure of splenic vessels to erosive pancreatic juice and the preservation of splenic vessels itself may explain the higher chance of PPH in KT. Larger volume studies are warranted to confirm this finding and to clarify the clinical significance. This study compared the perioperative outcomes between the two spleen-preserving techniques, with a focus on parameters relating to perioperative patient safety. Especially, the incidence and clinical relevance of PPH in SP-MIDP were evaluated.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital, School of Medicine, Zhejiang University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- pathological diagnosis of benign or low-grade malignant pancreas tumors.
Exclusion Criteria:
- incomplete medical records,
- history of previous splenectomy,
- high-grade malignant pancreas tumors,
- conversion to open DP (ODP).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Kimura technique (KT)
Spleen preservation is accomplished by sparing the splenic vessels.
|
preservation the splenic vessels
|
|
Warshaw technique (WT)
Spleen preservation is accomplished by sacrificing the splenic vessels and maintaining vascularity through the preserved short gastric and left gastroepiploic vessels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
major complications
Time Frame: Within 30 days of SP-MIDP
|
(Clavien-Dindo grade ≥ III)
|
Within 30 days of SP-MIDP
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liang Tingbo, Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP-MIDP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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