Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

Conditions: Acute Pancreatitis

Treatments: Procedure: surgical intervention after percutaneous catheter drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT01527084

8760PG11

Details and patient eligibility

About

1. To determine the appropriate timing of surgical intervention after Percutaneous Catheter Drainage (PCD) in infected pancreatic necrosis (IPN).
2. To see the change in morbidity and mortality after changing the interval of surgery after PCD

Full description

In present study we plan to determine the appropriate timing of surgical intervention after PCD in step up approach of Infected pancreatic necrosis (IPN).

The investigators also intend to evaluate the role of PCD in obviating the surgical intervention in the management of IPN and evaluate the risks & benefits of extended treatment policy of PCD in step up approach of IPN in comparison to early surgery after PCD.

Enrollment: 40 patients

Sex: All

Ages: 14 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with diagnosis of IPN (UK GUIDELINES) managed with percutaneous catheter drainage (PCD) for 10 to 15 days and not showing significant improvement on PCD will be included

Exclusion criteria

1. Patient showing significant improvement on PCD within 10 days of its insertion.(Significant improvement on PCD is defined as resolution of fever, acceptance of enteral nutrition, decrease in total leukocyte count, reversal of organ system failure)
2. Sterile pancreatic necrosis
3. An acute intra abdominal event ( perforation of hollow viscus, bleeding, or the abdominal compartment syndrome) during or within 10 days after PCD insertion
4. Previous drainage or surgical necrosectomy for infected pancreatic necrosis (ERCP with or without papillotomy is allowed.)
5. Previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Group A

Other group

Description:

undergo surgery between days 10 - 15 after PCD

Treatment:

Procedure: surgical intervention after percutaneous catheter drainage

Group B

Other group

Description:

continued with PCD beyond 15 days and indications for surgery in them will be, 1. Persistent sepsis or symptoms 2. Worsening of clinical condition 3. Failure to thrive 4. Complications of SAP or PCD

Treatment:

Procedure: surgical intervention after percutaneous catheter drainage