Outcomes of Surgical Resection of Pancreatic Cystic Neoplasms Based on the European Expert Consensus Statement: A Prospective Observational Study.

Pancreas Cancer Clinical Trial

Official title:

Outcomes of Surgical Resection of Pancreatic Cystic Neoplasms Based on the European Expert Consensus Statement: A Prospective Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747600
• Other study ID #: zagazig PCN
• Status: Completed
• Start date: June 1, 2014
• Est. completion date: January 1, 2021

Study information

• Verified date: October 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Introduction: Pancreatic cystic neoplasms (PCNs) comprise neoplasms with a wide range of benign and malignant varieties. The most common include serous cystic neoplasms (SCNs), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), and solid pseudo-papillary neoplasms (SPPNs).

Endoscopic ultrasonography (EUS), computed tomography (CT) and magnetic resonance (MR) are used to diagnose different PCNs types. The cyst fluid aspiration and analysis is performed in difficult differential diagnosis. Frequently, amylase and CEA levels are measured. The choice of surgery depends on cyst location and size and includes pancreatico-duodenectomy or distal pancreatectomy.

Objectives: The aim of this study was to evaluate the outcomes after pancreatic surgery when adopted as the management of true exocrine epithelial cystic neoplasms.

Description:

Introduction: Pancreatic cystic neoplasms (PCNs) comprise neoplasms with a wide range of benign and malignant varieties. The most common include serous cystic neoplasms (SCNs), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), and solid pseudo-papillary neoplasms (SPPNs).

Endoscopic ultrasonography (EUS), computed tomography (CT) and magnetic resonance (MR) are used to diagnose different PCNs types. The cyst fluid aspiration and analysis is performed in difficult differential diagnosis. Frequently, amylase and CEA levels are measured. The choice of surgery depends on cyst location and size and includes pancreatico-duodenectomy or distal pancreatectomy.

Objectives: The aim of this study was to evaluate the outcomes after pancreatic surgery when adopted as the management of true exocrine epithelial cystic neoplasms.

Patients and methods: Between June 2014 and January 2018, 63 patients referred to our tertiary referral center with diagnosis of true exocrine cystic neoplasms of the pancreas accepted for surgery were included in the present prospective cohort study. Patients were categorized according to preoperative diagnosis into: serous cystic neoplasms (Group A: 30 patients), mucinous cystic neoplasms (Group B: 13 patients), intra-papillary mucinous neoplasms (Group C: 9 patients), whereas the last 5 patients diagnosed as solid pseudo-papillary neoplasms (Group D). Demographic data, perioperative data and univariate analysis for malignancy, recurrence and pancreatic fistula were collected and analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• any Age

• both sex,

• expected R0 resection,

• Tumor of any size,

• no previous pancreatic surgery with diagnosis of True exocrine pancreatic cystic neoplasms

Exclusion Criteria:

• endocrinal pancreatic tumors,

• solid pancreatic tumors,

• previous pancreatic surgery,

• recurrent pancreatic tumor,

• Combined operation,

• prior history of any malignancy and misdiagnosed cases discovered on postoperative pathological cases as pancreatic pseudo-cyst or endocrine tumors

Related Conditions & MeSH terms

• Neoplasms
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• surgical resection
surgical resection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of the pancreatic fistula	detect pancreatic fistula by concentration of amylase level in drain	30 days postoperatively
Secondary	recurrence rate in percentage	rate of recurrence after resection by computed tomography	2.5 years