Distal Pancreatectomy Clinical Trial
Official title:
Comparison of Outcomes Between Warshaw and Kimura Techniques for Spleen-preserving Minimally Invasive Distal Pancreatectomy: With a Specific Focus on Perioperative Patient Safety
NCT number | NCT06084975 |
Other study ID # | SP-MIDP |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | December 31, 2022 |
Verified date | October 2023 |
Source | Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 314 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
China | the First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | major complications | (Clavien-Dindo grade = III) | Within 30 days of SP-MIDP |
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