Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery

Medical University of Vienna

Status: Completed

Conditions: Surgery; Improvement of Perioperative Outcome; Pancreatic Cancer

Treatments: Procedure: antecolic reconstruction; Procedure: retrocolic reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT01248663

2006-020

Details and patient eligibility

About

Pancreaticoduodenectomy (whipple procedure) is the standard operation for tumors of the pancreatic head, uncinate process, distal common bile duct as well as the papilla of vater. For reconstruction, pylorus-preservation (PPPD) has been shown to be technically and oncologically equivalent to the traditional whipple operation. One issue with this technique is delayed gastric emptying (DGE), which occurs in 25-70% of patients, usually emerging between day 4 and 14 after surgery. Patients with severe DGE can not only experience prolonged length of hospital stay, but are also at increased risk for other complications like aspiration or other issues related to the inability to ingest nutrition.

There is vast retrospective evidence and one prospective study indicating that antecolic reconstruction of the duodenojejunostomy can improve the rate and severity of delayed gastric emptying.

The investigators have conducted a prospective randomized trial in order to test this hypothesis. Patients were randomized to either undergo antecolic or retrocolic reconstruction after PPPD. On day 10 after surgery, DGE was assessed by clinical criteria. In addition, a test meal including 1g paracetamol was administered to check for clinically inapparent DGE. Of these serum samples, kinetics of intestinal peptides like GLP-1, PYY and glucagon was alos measured.

Enrollment: 64 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• verified cancer of the pancreatic head/neck/uncinate process or distal bile duct, radiographically suspicious tumor requiring pancreaticoduodenectomy
• pylorus-preserving reconstruction planned
• no evidence of distant metastases
• written informed consent

Exclusion criteria

• age <18 or >90 years
• status post surgical resection of stomach or duodenum
• locally unresectable:
• invasion of the hepatic artery/superior mesenteric artery
• >180 deg invasion of portal vein/superior mesenteric vein
• gastric invasion
• hypersensitivity to paracetamol
• clinically significant anastomotic dehiscence
• postoperative pancreatitis > day 10
• preoperative evidence of gastroparesis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

antecolic reconstruction

Active Comparator group

Description:

After completion of pancreaticoduodenectomy and reconstruction of the pancreaticojejunostomy and hepaticojejunostomy, the reconstruction of the intestinal passage will be conducted by performing an antecolic duodeno-jejunostomy

Treatment:

Procedure: antecolic reconstruction

retrocolic reconstruction

Experimental group

Description:

After completion of pancreaticoduodenectomy and reconstruction of the pancreaticojejunostomy and hepaticojejunostomy, the reconstruction of the intestinal passage will be conducted by performing a retrocolic duodeno-jejunostomy

Treatment:

Procedure: retrocolic reconstruction