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True Exocrine Epithelial Pancreatic Cystic Neoplasms Based on European Expert Consensus Statement on Pancreatic Cystic Neoplasms 2013.

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ClinicalTrials.gov Identifier: NCT04747600
Recruitment Status : Completed
First Posted : February 10, 2021
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Tamer Alsaied Alnaimy, Zagazig University

Study Description
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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.


Condition or disease Intervention/treatment
Pancreas Cancer Procedure: surgical resection

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Laparoscopic Surgical Resection of True Exocrine Epithelial Pancreatic Cystic Neoplasms Based on European Expert Consensus Statement on Pancreatic Cystic Neoplasms 2013. Critical Appraisal of the Old and Recent Consensus. Prospective Cohort Study.
Actual Study Start Date : June 1, 2014
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
serous cystic neoplasms Procedure: surgical resection
surgical resection
mucinous cystic neoplasms Procedure: surgical resection
surgical resection
intra-papillary mucinous neoplasms Procedure: surgical resection
surgical resection
solid pseudo-papillary neoplasms Procedure: surgical resection
surgical resection


Outcome Measures
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Primary Outcome Measures :
  1. the incidence of the pancreatic fistula [ Time Frame: 30 days postoperatively ]
    detect pancreatic fistula by concentration of amylase level in drain


Secondary Outcome Measures :
  1. recurrence rate in percentage [ Time Frame: 2.5 years ]
    rate of recurrence after resection by computed tomography


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Tamer Alsaied Alnaimy, assistant professour of general and laparoscopic surgery, Zagazig University
ClinicalTrials.gov Identifier: NCT04747600    
Other Study ID Numbers: zagazig PCN
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases