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

NCT04747600 | Completed

• 1 other identifier: zagazig PCN
• Study Type: observational
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• the incidence of the pancreatic fistula

  detect pancreatic fistula by concentration of amylase level in drain

  30 days postoperatively

Secondary Outcomes (1)

• recurrence rate in percentage

  2.5 years

Study Arms (4)

serous cystic neoplasms

Procedure: surgical resection

mucinous cystic neoplasms

Procedure: surgical resection

intra-papillary mucinous neoplasms

Procedure: surgical resection

solid pseudo-papillary neoplasms

Procedure: surgical resection

Interventions

surgical resection PROCEDURE

surgical resection

intra-papillary mucinous neoplasms; mucinous cystic neoplasms; serous cystic neoplasms; solid pseudo-papillary neoplasms

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 63 patients with a clinical diagnosis of true exocrine pancreatic cystic neoplasms were enrolled in this prospective cohort study as a comprehensive sampling in our hepato-biliary pancreatic unit of our university hospital between June 2014 to January 2018. They were categorized into 4 groups: Group A(30 patients)that were diagnosed as serous cystic neoplasms, Group B(19 patients) that were diagnosed as mucinous cystic neoplasms, Group C(9 patients )that were diagnosed as intra-ductal papillary mucinous neoplasms and Group D(5 patients ) that were diagnosed as solid pseudo-papillary neoplasms.

You may qualify if:

• any Age
• both sex,
• expected R0 resection,
• Tumor of any size,
• no previous pancreatic surgery with diagnosis of True exocrine pancreatic cystic neoplasms

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professour of general and laparoscopic surgery

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 10, 2021
• Study Start: June 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2021
• Last Updated: October 10, 2022

Record last verified: 2022-10