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

Ductal Adenocarcinoma of the Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119776
• Other study ID #: 202004002RINA
• Status: Recruiting
• Start date: May 20, 2020
• Est. completion date: May 20, 2025

Study information

• Verified date: August 2023
• Source: National Taiwan University Hospital
• Contact: Ting-Chun Kuo
• Phone: +88623123456
• Email: tinakuo1204[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 20, 2025
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• pancreatic ductal cell adenocarcinoma (PDCA) patients

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Ductal Adenocarcinoma of the Pancreas

Intervention

Procedure:
• Whipple over the splenic artery
Treatment for pancreatic ductal cell adenocarcinoma
• Total pancreatectomy
Treatment for pancreatic ductal cell adenocarcinoma

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Measurement of the physiological parameters	1 day before the operation
Other	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Measurement of the physiological parameters	3 months after the operation
Other	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Measurement of the physiological parameters	6 months after the operation
Primary	Clinicopathological characteristics	Measurement of the remnant pancreatic volume	before
Primary	Clinicopathological characteristics	Measurement of the remnant pancreatic volume	1 week after the operation
Secondary	Postoperative chemotherapy and follow-up	Measurement of the remnant pancreatic volume and physiological parameters	1 month after the operation