NCT02041793

Brief Summary

This study is a randomized controlled trial comparing Laparoscopic and endoscopic drainage for pseudocyst of the pancreas secondary to acute pancreatitis. The primary outcome measure will be resolution of the pseudocyst by the intended treatment within 4 weeks. The secondary outcomes will be complications, recurrence and cost analysis between the two methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

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

Study Start

First participant enrolled

May 1, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

4.9 years

First QC Date

July 10, 2013

Last Update Submit

June 29, 2017

Conditions

Pancreatic Pseudocyst

Keywords

Acute pancreatitisPseudocyst

Outcome Measures

Primary Outcomes (1)

  • Resolution of Pseudocyst

    resolution on imaging

    4 weeks

Secondary Outcomes (3)

  • Adverse Events

    4 weeks

  • Cost per patient

    4 weeks

  • Recurrence rate of pseudocyst

    3 months

Study Arms (2)

Laparoscopic cystogastrostomy

ACTIVE COMPARATOR

Laparoscopic cystogastrostomy will be performed by using a stapled cystogastrostomy

Procedure: Laparoscopic cystogastrostomy

Endoscopic cystogastrostomy

ACTIVE COMPARATOR

Endoscopic cystogastrostomy or cystoduodenostomy will be performed either under direct endoscopic or endosonography guidance.

Procedure: Endoscopic cystogastrostomy

Interventions

Laparoscopic cystogastrostomyPROCEDURE

Patients undergo drainage of pseudocyst by laparoscopic technique

Laparoscopic cystogastrostomy
Endoscopic cystogastrostomyPROCEDURE

Endoscopic cystogastrostomy or cystoduodenostomy will be performed either under direct endoscopic or endosonography guidance

Endoscopic cystogastrostomy

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic patients with pseudocyst of size more than 6 cm, more than 6-8 weeks duration after an attack of acute pancreatitis.

You may not qualify if:

  • Patients with chronic pancreatitis associated pseudocyst.
  • Patients who have undergone any form of intervention previously
  • Patients with significant co-morbidities
  • Patients unfit for general anesthesia
  • Bleeding disorders
  • Patients refusing consent
  • Patients having significant necrotic debris not considered fit for endoscopic drainage. The presence of necrotic debris will be assessed by ultrasound of the abdomen and if required magnetic resonance imaging. The volume of the cyst and that of necrotic debris will be calculated and significant debris will be defined as \>30% of debris volume/volume
  • Presence of a pseudoaneurysm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (1)

  • Aljarabah M, Ammori BJ. Laparoscopic and endoscopic approaches for drainage of pancreatic pseudocysts: a systematic review of published series. Surg Endosc. 2007 Nov;21(11):1936-44. doi: 10.1007/s00464-007-9515-2. Epub 2007 Aug 24.

    PMID: 17717626RESULT

MeSH Terms

Conditions

Pancreatic PseudocystPancreatitis

Condition Hierarchy (Ancestors)

Pancreatic CystCystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Officials

  • Virinder K Bansal, MS

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Pramod K Garg, MD

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor

Study Record Dates

First Submitted

July 10, 2013

First Posted

January 22, 2014

Study Start

May 1, 2010

Primary Completion

April 1, 2015

Study Completion

November 1, 2015

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

IN(1)