Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study

Recruiting

• Conditions: Ductal Adenocarcinoma of the Pancreas
• Interventions: Procedure: Whipple over the splenic artery; Procedure: Total pancreatectomy

• Registration Number: NCT06119776
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).

Detailed Description

Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).

Methods: The study group comprised 40 consecutive patients who underwent WOTSA for PDAC. Their clinicopathological characteristics and survival were compared with those of a historical control group comprising 30 consecutive patients who underwent TP between.

Study Timeline

• Study Start: 2020-05-20
• Primary Completion: 2020-05-20
• Status Verified: 2023-08
• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Study Completion: 2025-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• pancreatic ductal cell adenocarcinoma (PDCA) patients

Exclusion Criteria

• Patient undergoing palliative pancreatectomy, other malignancies with distant metastases
• Vulnerable groups

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study	Whipple over the splenic artery	Patients who underwent Whipple over the splenic artery (WOTSA) as a treatment for PDAC
Control	Total pancreatectomy	Patients who underwent total pancreatectomy (TP) as a treatment for PDAC

Primary Outcome Measures

Name	Time	Method
Clinicopathological characteristics	1 week after the operation	Measurement of the remnant pancreatic volume

Secondary Outcome Measures

Name	Time	Method
Postoperative chemotherapy and follow-up	1 month after the operation	Measurement of the remnant pancreatic volume and physiological parameters

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan