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OpenTrials
Completed

NCT Number: NCT04747600

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical resection

Procedure

surgical resection

Primary outcomes

  1. the incidence of the pancreatic fistula

    Time frame: 30 days postoperatively

    detect pancreatic fistula by concentration of amylase level in drain

Secondary outcomes

  1. recurrence rate in percentage

    Time frame: 2.5 years

    rate of recurrence after resection by computed tomography

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2021
First posted
Feb 10, 2021
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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