Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis

NCT ID: NCT02084537

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-09-30

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.

Detailed Description

Patients will be randomly allocated to either treatment arm in a 1:1 ratio. Following intervention, patients will be assessed at regular intervals until study completion at 6 months post-discharge. Primary outcome is a composite of major complications and/or mortality, measured to 6 months post-discharge.

Conditions

Necrosis of Pancreas; Infected Pancreatic Necrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic treatment

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.

Group Type: ACTIVE_COMPARATOR

Endoscopic treatment

Intervention Type: PROCEDURE

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.

Minimally invasive surgical necrosectomy

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

Group Type: ACTIVE_COMPARATOR

Minimally invasive surgical necrosectomy

Intervention Type: PROCEDURE

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

Interventions

Endoscopic treatment

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.

Intervention Type: PROCEDURE

Minimally invasive surgical necrosectomy

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

Intervention Type: PROCEDURE

Other Intervention Names

Endoscopic cystogastrostomy; Endoscopic cystoduodenostomy; Endoscopic necrosectomy; Video-assisted retroperitoneal debridement (VARD); Laparoscopic cystogastrostomy with internal debridement

Eligibility Criteria

Inclusion Criteria

• 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.
• 18 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.

Exclusion Criteria

• <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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AdventHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shyam S Varadarajulu, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

Florida Hospital Center for Interventional Endoscopy

Orlando, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30452918 (View on PubMed)

Other Identifiers

577235

Identifier Type: -

Identifier Source: org_study_id