Clinical trial NCT01248663: Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery
Official title: Influence of the Reconstruction Method on the Incidence of Delayed Gastric Emptying After Pylorus Preserving Pancreaticoduodenectomy. A Prospective, Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Surgery
Improvement of Perioperative Outcome
Keywords: pancreatic cancer
pylorus-preserving pancreaticoduodenectomy
delayed gastric emptying
reconstruction
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Delayed gastric emptying
timeFrame: Postoperative day 10
Secondary outcomes:
measure: Paracetamol reabsorption test
timeFrame: postoperative day 10
measure: Measurement of plasma intestinal peptides
timeFrame: postoperative day 10
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Michael Gnant, MD
role: PRINCIPAL_INVESTIGATOR
References: