Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pancreatic Cancer Surgery Improvement of Perioperative Outcome |
Procedure: antecolic reconstruction Procedure: retrocolic reconstruction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Influence of the Reconstruction Method on the Incidence of Delayed Gastric Emptying After Pylorus Preserving Pancreaticoduodenectomy. A Prospective, Randomized Trial. |
- Delayed gastric emptying [ Time Frame: Postoperative day 10 ] [ Designated as safety issue: No ]Gastric emptying will be assessed by clinical criteria on postoperative day 10 after pylorus-preserving pancreatico-duodenectomy.
- Paracetamol reabsorption test [ Time Frame: postoperative day 10 ] [ Designated as safety issue: No ]On day 10 after pylorus-preserving pancreaticoduodenectomy, a test meal of a commercially available dietary product (Fresubin protein energy(c)) and 1g paracetamol will be administered. Serum levels of paracetamol will be measured at 0, 15, 30, 60 and 90 minutes after administration.
- Measurement of plasma intestinal peptides [ Time Frame: postoperative day 10 ] [ Designated as safety issue: No ]On day 10 after pylorus-preserving pancreaticoduodenectomy, a test meal of a commercially available dietary product (Fresubin protein energy(c)) and 1g paracetamol will be administered. Serum levels of glucagon-like peptide-1 (GLP-1), peptide YY (PYY) and Glucagon will be measured at 0, 15, 30, 60 and 90 minutes after administration.
| Enrollment: | 64 |
| Study Start Date: | April 2007 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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
|
Procedure: antecolic reconstruction
see study arm description
|
|
Experimental: 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
|
Procedure: retrocolic reconstruction
see study arm description
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Michael Gnant, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01248663 History of Changes |
| Other Study ID Numbers: | 2006-020 |
| Study First Received: | November 24, 2010 |
| Last Updated: | November 24, 2010 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Medical University of Vienna:
|
pancreatic cancer pylorus-preserving pancreaticoduodenectomy delayed gastric emptying reconstruction |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Gastroparesis Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases |
Pancreatic Diseases Endocrine System Diseases Stomach Diseases Gastrointestinal Diseases Paralysis Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013