True Exocrine Epithelial Pancreatic Cystic Neoplasms Based on European Expert Consensus

Sponsor

Zagazig University (Other)

Overall Status

Completed

CT.gov ID

NCT04747600

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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	Phase
Pancreas Cancer	Procedure: surgical resection

Detailed Description

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

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 the European Expert Consensus Statement on Pancreatic Cystic Neoplasms. A Prospective Multicenter Observational Study.

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	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

Primary Outcome Measures

the incidence of the pancreatic fistula [30 days postoperatively]
detect pancreatic fistula by concentration of amylase level in drain

Secondary Outcome Measures

recurrence rate in percentage [2.5 years]
rate of recurrence after resection by computed tomography

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Feb 10, 2021

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Pancreatic Neoplasms

Study Results

No Results Posted as of Apr 29, 2022