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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2023
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Splenic vessels preservation
preservation the splenic vessels

Locations

Country Name City State
China the First Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary major complications (Clavien-Dindo grade = III) Within 30 days of SP-MIDP
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