Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy

Wakayama Medical University

Status: Completed

Conditions: Bile Duct Cancer; Pancreatitis; Ampullary Cancer; Pancreatic Cancer; Duodenal Cancer

Treatments: Device: internal drainage tube [polyethylene pancreatic drainage tube]; Device: external drainage tube [polyethylene pancreatic drainage tube]

Study type: Interventional

Funder types: Other

Identifiers

NCT00628186

WP-0501

Details and patient eligibility

About

The purpose of this study is to determine which stent type is effective in the decrease of postoperative stay and complications across pancreaticojejunostomy after pancreaticoduodenectomy.

Full description

This study compared the postoperative hospital stay and complications of lost stent with external stent after pancreaticoduodenectomy. The complications of pancreaticoduodenectomy are important to affect the postoperative course, and, a stent tube often places across pancreaticojejunostomy to reduce complications. However, there is no report that demonstrates the postoperative course between pancreatic stent types. We conducted a prospective randomized trial on 100 patients who underwent pancreaticoduodenectomy comparing external stent and lost stent.

The primary endpoint was defined as postoperative hospital stay. The secondary endpoints were mortality and morbidity, including pancreatic fistula, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients who were diagnosed inadequacy for this study by a physician, 3) patients who could not be placed a pancreatic stent tube, and 4) patients without an informed consent.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• On the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained.

Exclusion criteria

• Patients with severe complications which were possible to prolong hospital stay
• Patients who were diagnosed inadequacy for this study by a physician
• Patients who could not be placed a pancreatic stent tube
• Patients without an informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

1

Experimental group

Description:

Pancreaticojejunostomy has a risk factor of pancreatic fistula. Type of stent tube (external stent vs. short stent)across pancreaticojejunostomy was randomized for the patients with pancreaticoduodenectomy.

Treatment:

Device: external drainage tube [polyethylene pancreatic drainage tube]

Device: internal drainage tube [polyethylene pancreatic drainage tube]