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Quality of Life After Bilioenteric Anastomosis in Comparison to Endoscopically Placed Stents in Patients With Unresectable Pancreatic Cancer and Jaundice


Phase 4
18 Years
90 Years
Open (Enrolling)
Both
Local Tumor Spread, Advanced Cancer, Metastasized, Pancreatic Cancer Non-resectable, Jaundice

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Trial Information

Quality of Life After Bilioenteric Anastomosis in Comparison to Endoscopically Placed Stents in Patients With Unresectable Pancreatic Cancer and Jaundice


The aim of this multi-centre, prospective-randomised study was to compare the effectiveness
of palliative applications on patients suffering from a local, advanced and/or hepatic,
metastasising, non-resectable pancreas head carcinoma and jaundice.

Before randomisation, all patients are fitted with an endoscopically inserted biliary tract
drainage endoscopically inserted. When postoperatively ascertained that the pancreas head
carcinoma is non-resectable, the patient shall be electronically registered and randomly
assigned to one of the palliative strategies. Group 1 will be fitted with a biliodigestive
anastomosis. Group 2 will continue with the endoscopically inserted drainage. Regardless of
which group they belong to, all patients will receive a palliative chemotherapy.

The primary parameter is the average quality of life over a period of 6 months post-OP, to
be analysed monthly using identical questionnaires. The comparison of the randomisation
groups will be carried out using a co-variance analysis (ANCOVA) with the initial value,
taken directly before the OP, to be used as co-variant.


Inclusion Criteria:



1. Adult patient with local, advanced adenocarcinoma of the pancreas head and jaundice.

2. Performance-status of 50 or above on the Karnofsky-scale (see attachment).

3. Adequate bone marrow reserves: leukocyte level > 3.5 x 10┬┤/l, thrombocyte level level
> 100 x 10/l; Haemoglobin> 80g/l.

4. Male or female patients, at least 18 years old.

5. Women of child bearing age must be sufficient protected against pregnancy
(contraception) during and for 3 months after the end of the study.

Exclusion Criteria:

1. Adult patients with focal, advanced adenocarcinoma of the pancreas head and no
jaundice; also no jaundice in their anamnesis and with no ERCP-induced intervention.

2. Pregnancy

3. Breast feeding

4. Contra-indication for gemcitabine

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Outcome of Quality of Life.

Outcome Time Frame:

2 1/2 years

Safety Issue:

Yes

Principal Investigator

Jacob R Izbicki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universit├Ątsklinik Hamburg

Authority:

Germany: Ethics Commission

Study ID:

1 - mtachezy

NCT ID:

NCT01887041

Start Date:

January 2010

Completion Date:

July 2015

Related Keywords:

  • Local Tumor Spread
  • Advanced Cancer
  • Metastasized
  • Pancreatic Cancer Non-resectable
  • Jaundice
  • Advanced, metastasising pancreatic head carcinoma
  • Jaundice
  • Biliodigestive anastomosis
  • Endoscopically inserted biliary tract drainage
  • Quality of Life
  • Jaundice
  • Neoplasm Metastasis
  • Pancreatic Neoplasms
  • Neoplasms

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