Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Pancreatic Fistula; Pancreatectomy

Treatments: Procedure: No Stent; Procedure: Pancreatic Stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT05297136

2021.728-T

Details and patient eligibility

About

Distal pancreatectomy (DP) with or without splenectomy is commonly indicated for pancreatic body or tail lesions. Postoperative pancreatic fistula (POPF) remains the commonest complication after DP. A pre-operatively placed pancreatic stent across papilla can decrease the pressure gradient between pancreatic duct and duodenum. Therefore, the pancreatic juice flow is redirected from the pancreatic transection plane and leakage from pancreatic stump is much reduced. This study aims to evaluate whether pre-operatively placed pancreatic stent can prevent POPF by a randomized controlled trial.

Full description

A randomised-controlled trial is performed to evaluate the efficacy of preoperative pancreatic duct stenting in preventing post-operative pancreatic fistula after distal pancreatectomy with or without splenectomy. Patients will be randomised to pre-operative stent group or surgery alone group. Pre-operative pancreatic duct stenting will be performed 1-2 weeks before surgery. The stent will be removed 4 weeks after operation. The post-operative pancreatic fistula rate, morbidity, mortality and total length of stay were compared between the 2 groups.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years
• Elective distal pancreatectomy for primary pancreatic pathology

Exclusion criteria

• Informed consent not available
• Emergency distal pancreatectomy
• Presence of pancreatic duct stricture
• Presence of altered anatomy that precludes safe Endoscopic Retrograde Cholangiography (e.g. previous Billroth II gastrectomy)
• History of severe pancreatitis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Pre-op Stenting

Experimental group

Description:

Pre-operative pancreatic stent inserted by Endoscopic Retrograde Cholangiography, followed by distal pancreatectomy

Treatment:

Procedure: Pancreatic Stenting

Surgery alone

Active Comparator group

Description:

Distal pancreatectomy alone

Treatment:

Procedure: No Stent