Clinical trial NCT06119776: Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study
Official title: Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ductal Adenocarcinoma of the Pancreas
Keywords: Ductal Adenocarcinoma
Pancreatectomies
Whipple
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pancreatic ductal cell adenocarcinoma (PDCA) patients

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.

Eligibility criteria: Inclusion Criteria:

* pancreatic ductal cell adenocarcinoma (PDCA) patients

Exclusion Criteria:

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

Primary outcomes:
measure: Clinicopathological characteristics
timeFrame: before
measure: Clinicopathological characteristics
timeFrame: 1 week after the operation
Secondary outcomes:
measure: Postoperative chemotherapy and follow-up
timeFrame: 1 month after the operation
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 day before the operation
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 3 months after the operation
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 months after the operation
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: