Skip to content

Comparing two slicing techniques in the pathological assessment of pancreas specimens in persons who undergo a Whipple resection

Axial slicing versus bivalving of the pancreatic head in the pathological examination of pancreatoduodenectomy specimens: a multicenter, randomized, controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12141624
Enrollment
128
Registered
2019-04-30
Start date
2018-08-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients that undergo elective pancreatoduodenectomy for a malignant or premalignant periampullary lesion Cancer

Interventions

Participants will be randomised to one of two treatment arms: 1. Axial slicing according to Verbeke: Parallel margins (en face) from the pancreatic neck margin, proximal distal bile du

Sponsors

Amsterdam UMC, location AMC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All patients that undergo pancreatoduodenectomy

Exclusion criteria

Exclusion criteria: 1. Pancreatoduodenectomy performed for chronic pancreatitis 2. Pancreatoduodenectomy preoperatively confirmed neuro-endocrine tumors and hamoudi / acinar cell tumors 3. Pancreatoduodenectomy performed for tumors outside the periampullary region

Design outcomes

Primary

MeasureTime frame
Level of certainty in determining the primary origin of the tumor by 4 pathologists. Pathologists assess the macroscopic photos of each specimen and score how certain they are of the primary origin of the tumor (0-100%) in a survey.

Secondary

MeasureTime frame
1) Inter-observer agreement (kappa) among different pathologists in origin of the tumor (by survey) 2) R1 rate for pancreatic and periampullary cancers/lymph node harvest Both determined during routine pathological examination.

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026