Current partner codePEPTIDESDE
NCT01094600·Not applicable·INTERVENTIONAL

Comparison of Secretin-enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) to Endoscopic Pancreatic Function Test (ePFT) in Diagnosing Pancreatic Exocrine Insufficiency

Status

Withdrawn

Phase

Not applicable

Enrollment

0

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The aim of our study is to evaluate S-MRCP, in comparison to direct pancreatic function, to measure pancreatic exocrine function in patients who have symptoms suspicious for insufficiency. We hypothesize that S-MRCP imaging parameters will correlate well with the direct pancreatic exocrine functioning.

Full detailed description

Surgical resection offers the only hope of cure for pancreatic adenocarcinoma. While perioperative mortality rates have declined in recent years, pancreatic resection is still associated with significant postoperative malnutrition, maldigestion, and glucose intolerance, mostly as a result of pancreatic insufficiency. Quantifying individual pancreatic function remains a challenge, but is essential in improving the survival and quality of life of pancreatic cancer patients. Secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP) has recently emerged as a widely-accepted noninvasive technique to assess morphological changes in pancreatic ducts, as well as functional secretory capacity of the gland. The aim of our study is to evaluate S-MRCP as a means to evaluate for pancreatic exocrine insufficiency. This will be a prospective study of twelve patients who have undergone pancreatic resection and who have symptoms of abdominal pain, steatorrhea or weight loss. We will be comparing quantitative parameters of S-MRCP (maximal change in pancreatic duct diameter and volume before and after secretin administration) with endoscopic pancreatic function testing (maximal bicarbonate concentration in duodenal aspirate after secretin administration).

Interventions

Treatment arms and agents.

DRUG

Synthetic Human Secretin

Twelve patients will undergo S-MRCP, at a dose of 0.2 ucg/kg per exam. Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.

Timeline

From registration to results.

  1. First posted

    Mar 29, 2010

  2. Study start

    Jun 2012

  3. Primary completion

    Jun 2012

  4. Study completion

    Jun 2012

  5. Results posted

    Not reported

  6. Registry updated

    Jul 2, 2012

Outcomes

What the study measures.

Primary outcomes

Primary outcome: correlation between S-MRCP with ePFT

Time frame · 30 days

The primary outcome that we will be measuring will be correlation between duodenal filling on S-MRCP (expressed as percent of duct volume change from baseline and maximal values following secretin administration) with maximal bicarbonate concentration from ePFT.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 18 years of age and older * Tissue-confirmed diagnosis of pancreatic adenocarcinoma * Undergone surgical resection for adenocarcinoma no less than 3 months prior to enrollment * Report significant abdominal pain/bloating or steatorrhea \>3x/week or demonstrate weight loss corresponding to \>10% of pre-surgery BMI. * Scheduled for EGD/EUS to investigate the above clinical indicators. Exclusion Criteria: * History of any radiation therapy to the abdomen prior to surgery * Any contraindication to MRI, including but not limited to implanted metal devices (e.g. pacemaker, berry aneurysm clips, neural stimulator, cochlear implants, or metal in the eye) * Presence of pancreatic duct stent * Treatment with an investigational drug within 1 month prior to the day of the study drug administration * Current enrollment in any other interventional study * Creatinine greater than 2.0 * Significant liver disease, liver masses, or evidence of portal hypertension * Pregnancy * History of sensitivity to secretin * Unwilling or unable to sign informed consent

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

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Put the record in context.

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