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Clinical trial to assess efficiency of minimally invasive surgery in severe pancreatitis

Early minimally invasive surgery versus extended percutaneous drainage in step-up approach in infected pancreatic necrosis: a randomized controlled trial. - EARMIDS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012500
Enrollment
50
Registered
2018-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute Pancreatitis (Severe and moderately severe)

Interventions

Intervention1: Early Surgery Arm: This group of patients will taken up for video assisted retroperitoneal debridement (VARD). The patient was placed in supine position with the left side 30 degrees el

Sponsors

Rajesh Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with moderately severe and severe acute pancreatitis who are being managed with percutaneous catheter drainage for three to seven days and who deteriorated or did not show significant improvement on PCD treatment alone.

Exclusion criteria

Exclusion criteria: 1. Traumatic pancreatitis 2. Previous intervention for pancreatitis like surgical/ endoscopic necrosectomy 3. Significant improvement after PCD insertion. (Improvement was characterized by tolerance to oral feeds, falling WBC counts, resolution of organ failure, defervescence)

Design outcomes

Primary

MeasureTime frame
1.Mortality in the two groups 2. Morbidity in the two groups 3. Duration of hospital stay 4. Proportion of patients who required surgery in group B 5. Proportion of patients who required conventional open necrosectomy in both groupsTimepoint: Till discharge from hospital

Secondary

MeasureTime frame
Bleeding/Perforation of a visceral organ/ Enterocutaneous fistula requiring intervention Timepoint: Till discharge from hospital;New onset organ failure/sepsis/systemic complication Timepoint: Till discharge from hospital;Pancreatic fistula formationTimepoint: Till discharge from hospital;Reversal of existing organ failure/sepsis/systemic complication Timepoint: Till discharge from hospital;Total number of PCD/ other interventions requiredTimepoint: Till discharge from hospital

Countries

India

Contacts

Public ContactRajesh Gupta

PGIMER, CHANDIGARH

rajsarakshi@gmail.com7087009639

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026