A Novel Surgical Strategy to Reduce Major Complications in Patients With Necrotizing Pancreatitis

CompletedOBSERVATIONAL
Enrollment

271

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

December 31, 2021

Study Completion Date

October 1, 2022

Conditions
Acute Pancreatitis
Interventions
PROCEDURE

The novel PMMI surgical strategy

"Immediate drainagewas advocated within 24 hours once necrosis was diagnosed. During the treatment course, a hybrid approach was available by flexibly switching interventions. Open surgery was only applied when patients required emergency surgery.~The minimally invasive surgery was selected based on the size, location, and maturity of the necrotic area and stepwise response to intervention. Repeated peritoneal purification was performed until the infected or devitalized tissue was controlled. Patients were subsequently discharged with a drainage catheter and readmitted at 7- to 10-day intervals to receive repeated planned surgery without postoperative irrigation. Patients received a whole-course assessment for individual patients at 7-day predetermined intervals."

PROCEDURE

The conventional step-up strategy

Interventions were postponed until 4 weeks after the onset of pancreatitis in line with international guidelines unless the patient showed evidence of progressive clinical deterioration despite the use of maximal supportive care. Patients underwent CT-guided percutaneous catheter drainage as the first step. Treatment response was evaluated after 3 days. If drainage was clinically unsuccessful, a VARD procedure was performed. Similarly, open surgery, which was described by Beger et al., was performed if the VARD procedure failed. Postoperative continuous lavage is performed as a routine procedure.

Trial Locations (1)

Unknown

Tianjin NanKai Hospital, Tianjin

All Listed Sponsors
lead

Tianjin Nankai Hospital

OTHER

NCT06241586 - A Novel Surgical Strategy to Reduce Major Complications in Patients With Necrotizing Pancreatitis | Biotech Hunter | Biotech Hunter