NCT02084537

Brief Summary

Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy, in patients with necrotizing pancreatitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

3.8 years

First QC Date

March 10, 2014

Last Update Submit

February 8, 2019

Conditions

Necrosis of PancreasInfected Pancreatic Necrosis

Keywords

symptomaticinfectednecrotic collection

Outcome Measures

Primary Outcomes (1)

  • Major complications

    Composite of major complications and/or mortality (all cause and disease specific), measured to 6 months post discharge

    6 months post discharge

Study Arms (2)

Endoscopic treatment

ACTIVE COMPARATOR

Treated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7 French (Fr) double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed.

Procedure: Endoscopic treatment

Minimally invasive surgical necrosectomy

ACTIVE COMPARATOR

Video-assisted retroperitoneal debridement (VARD) or laparoscopic approach. This includes laparoscopic cystogastrostomy with internal debridement.

Procedure: Minimally invasive surgical necrosectomy

Interventions

Endoscopic treatmentPROCEDURE

Treated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7fr double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed.

Also known as: Endoscopic cystogastrostomy, Endoscopic cystoduodenostomy, Endoscopic necrosectomy
Endoscopic treatment
Minimally invasive surgical necrosectomyPROCEDURE

Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement.

Also known as: Video-assisted retroperitoneal debridement (VARD), Laparoscopic cystogastrostomy with internal debridement
Minimally invasive surgical necrosectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Necrotic collection
  • Infected (suspected and confirmed): clinical signs of infection (septic, positive cultures, febrile), systemic inflammatory response syndrome, gas within the collection on imaging (not iatrogenic), or positive culture of collection contents
  • Necrotic collection is within 15mm of the lumen of the gastrointestinal tract.
  • years and older
  • Informed consent obtained from the patient or their medical representative.
  • Medically fit for general anesthetic
  • Collection amenable to either endoscopic or minimally invasive surgical necrosectomy and drainage.

You may not qualify if:

  • \<18 years old
  • Unable to obtain informed consent from the patient or their medical representative.
  • Medically unfit for general anesthesia
  • Pregnant
  • Necrotic collection not accessible by either or both techniques
  • The collection is \>15mm from the lumen of the gastrointestinal tract.
  • Irreversible coagulopathy: International Normalized Ratio (INR) \>1.5
  • Irreversible thrombocytopenia: platelet count \<50 x10\^9/L
  • Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
  • Surgical or endoscopic necrosectomy or pseudocyst drainage has been performed within the preceding 12 months
  • Necrotic collection secondary to trauma or other surgical event that requires additional interventions such as management of liver lacerations or vascular injury.
  • Pre-existing percutaneous drain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital Center for Interventional Endoscopy

Orlando, Florida, 34786, United States

Location

Related Publications (1)

  • Bang JY, Arnoletti JP, Holt BA, Sutton B, Hasan MK, Navaneethan U, Feranec N, Wilcox CM, Tharian B, Hawes RH, Varadarajulu S. An Endoscopic Transluminal Approach, Compared With Minimally Invasive Surgery, Reduces Complications and Costs for Patients With Necrotizing Pancreatitis. Gastroenterology. 2019 Mar;156(4):1027-1040.e3. doi: 10.1053/j.gastro.2018.11.031. Epub 2018 Nov 16.

    PMID: 30452918DERIVED

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System Diseases

Study Officials

  • Shyam S Varadarajulu, MD

    AdventHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 12, 2014

Study Start

April 1, 2014

Primary Completion

December 31, 2017

Study Completion

September 30, 2018

Last Updated

February 11, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)