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Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery

NCT ID: NCT01248663

Last Updated: 2010-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer Surgery Improvement of Perioperative Outcome

Keywords

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pancreatic cancer pylorus-preserving pancreaticoduodenectomy delayed gastric emptying reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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antecolic reconstruction

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

Group Type ACTIVE_COMPARATOR

antecolic reconstruction

Intervention Type PROCEDURE

see study arm description

retrocolic reconstruction

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

Group Type EXPERIMENTAL

retrocolic reconstruction

Intervention Type PROCEDURE

see study arm description

Interventions

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antecolic reconstruction

see study arm description

Intervention Type PROCEDURE

retrocolic reconstruction

see study arm description

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna

Principal Investigators

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Michael Gnant, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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2006-020

Identifier Type: -

Identifier Source: org_study_id