Published September 2003
Prepared by the UKT Kidney and Pancreas Advisory Group
UK Transplant, a Special Health Authority
of the National Health Service
Fox Den Road, Stoke Gifford, BRISTOL BS34 8RR
1 INTRODUCTION
This protocol has been produced to reflect and amalgamate existing policies produced by the kidney and pancreas transplant centres in the UK and has been endorsed by the UK Transplant Pancreas Task Force.
2 INDICATIONS FOR SIMULTANEOUS KIDNEY PANCREAS TRANSPLANT
2.1 Simultaneous kidney pancreas transplant should be considered when the following criteria apply
- presence of insulin dependent type 1 diabetes mellitus
- chronic renal failure including either:
(a) predictive date of requiring dialysis is within 6 months; or
(b) on dialysis.
2.2 Contraindications to simultaneous kidney pancreas transplant
2.2.1 Absolute contraindications
- insufficient cardiovascular reserve including:
- angiography indicating clinically significant, severe and non-correctable coronary artery disease
- ejection fraction below 50%
- myocardial infarction within 6 months
- non-curable malignancy (excluding localised skin malignancy)
- active sepsis
- active peptic ulcer
- major psychiatric history likely to result in non-compliance
- inability to withstand surgery and immunosuppression.
2.2.2 Relative contraindications
- cerebrovascular accident with long term impairment
- HIV (subject to discussion with Medical Director at UK Transplant)
- Hepatitis B/Hepatitis C
- Body Mass Index greater than 30
- insulin requirements >1.5 units/kg/day
- extensive aorta/iliac and/or peripheral vascular disease
- continued abuse of alcohol, smoking or other drugs.
3 INDICATIONS FOR PANCREAS TRANSPLANT ALONE
3.1 Criteria
- presence of insulin dependent type 1 diabetes mellitus
- significant diabetic complications
- life threatening complications ie
- frequent and severe episodes of hypoglycaemia
- hypoglycaemia unawareness
- impairment of quality of life
- other metabolic or behavioural problems causing referral by a diabetologist.
3.2 Contraindications to pancreas transplant alone
3.2.1 Absolute contraindications
- insufficient cardiovascular reserve including:
- angiography indicating clinically significant and severe and non-correctable coronary artery disease
- ejection fraction below 50%
- recent myocardial infarction
- non-curable malignancy (excluding localised skin malignancy)
- active sepsis
- active peptic ulcer
- major psychiatric history likely to result in non-compliance
- inability to withstand surgery and immunosuppression.
3.2.2 Relative contraindications
- cerebrovascular accident with long term impairment
- HIV (subject to discussion with Medical Director at UK Transplant)
- Hepatitis B/Hepatitis C
- Body Mass Index greater than 30
- insulin requirements >1.5 units/kg/day
- extensive aorta/iliac and/or peripheral vascular disease
- continued abuse of alcohol, smoking or other drugs.
4 INDICATIONS FOR PANCREAS AFTER KIDNEY TRANSPLANT
4.1 Criteria
Patients with stable function of previous renal allograft that meet the criteria for pancreas transplant alone.
5 THE PANCREAS AND KIDNEY TRANSPLANT ASSESSMENT
5.1 Stages of assessment
- pre-transplant assessment
- decision
- transplant list.
5.2 Pre-transplant assessment
This may be conducted as either an inpatient or outpatient. The first assessment visit must be conducted within three months of referral (although the process may take longer) unless the patient is clearly unsuitable and a Consultant Physician/Surgeon has made this decision.
5.3 Objectives of assessment procedures
- The general principle of this assessment is attention to clinical detail and also avoidance of unnecessary tests if the patient is clearly deemed unsuitable for transplantation
- To assess the patient's clinical, social and psychological suitability as a transplant recipient
- To impart factual information to the patient and his/her family concerning all aspects of transplantation
- To meet hospital staff and transplant patients as appropriate
- To provide an opportunity for the patient, and his or her family, to begin to come to terms with the prospect of transplantation, and to be informed about the procedure and its aftermath.
5.4 Assessment
This will be carried out according to each unit's protocols and practices. The following serves as a guideline and is not intended to be exhaustive or prescriptive.
The importance of the multidisciplinary involvement in the assessment of the patient and care received is paramount. The assessment may involve a whole spectrum of healthcare professionals, including Physicians, Surgeons, Radiologists, Nurses, Transplant Co-ordinators, Occupational Therapists, Dieticians, Physiotherapists, Social Workers, Psychologists (if indicated, Psychiatrists) - everyone has a key role to play.
5.4.1 Clinical assessment
A full history and examination including:
5.4.2 Diabetic condition
History of diabetes - insulin dose, hypoglycaemic episodes,
unawareness.
Secondary complication of diabetes mellitus.
5.4.3 Social history
Marital status
Housing
Employment
Smoking
Drugs/alcohol abuse.
5.4.4 Past/concurrent history
Malignancy
Diabetes
Hypertension
Hypotension
Renal disease
Liver disease
Peripheral or cerebrovascular disease
Peptic ulceration, GI bleeding
Diverticular disease, GI sepsis
Unresolved sepsis in any site
Herpes virus infection
Previous blood transfusion.
5.4.5 Routine observations
Temperature
Blood pressure
Heart rate
Height
Weight
Peripheral pulses.
5.4.6 Radiology
Chest x-ray
Abdominal ultrasound of kidneys and gallbladder
Further assessment may be needed with ultrasound or CT scanning
Doppler and/or other imaging of aorta, iliac and peripheral
arteries may be indicated.
5.4.7 Microbiology assessment
MSU and urine test
Nose swab
MRSA screen.
5.4.8 Cardiac assessment
ECG
Echo
6-minute walk or other stress test
Ejection fraction test
Cardiology consultation that may include the need for additional
tests ie coronary angiogram as clinically indicated.
5.4.9 Dental assessment
Full dental examination
Advice on dental hygiene.
5.4.10 Ophthalmology assessment
Visual activity
Fluorescein Angiography
Retinal fundus photography with retinopathy score
Slit lamp examination.
5.4.11 Haematology blood tests
Blood group
Antibody screen (ABO)
Full blood count
Thrombophilia screen
APTT
PT, INR.
5.4.12 Biochemistry test
Urea & electrolytes
Creatinine
Uric acid
Calcium, phosphate
24-hour urine for protein/micro albuminuria and creatinine
clearance
GFR/Radioisotope glomerular filtration rate if needed
Kidney biopsy if indicated
Liver function tests
Amylase
Thyroid function
Fasting blood glucose
Fasting and stimulated C-peptide levels if needed
Fasting blood lipids.
Additional studies may include oral or intravenous glucose challenge, anti-insulin and islet cell antibodies, proinsulin level and lipoprotein.
5.4.13 Serology blood sample
Hepatitis B/HepatitisC
HIV
HTLV
EBK
Polioma virus
Syphilis
Rubella
Epstein Barr Virus
Toxoplasma
Varicella-zoster
Herpes simplex
Cytomegalovirus.
5.4.14 Immunology blood tests
HLA typing and antibody screening
Cross match.
5.4.15 Psychosocial assessment
Letter from GP confirming compliance with past therapy.
5.4.16 Other
Additional evaluations may be required by other healthcare
professionals as indicated.
6 FINAL DECISION
6.1 This may be carried out according to each unit's protocols and practices. However, the principles should be that the decision to place a patient on the waiting list is a multidisciplinary one. The patient and their relatives will be informed of the outcome and given the opportunity to discuss it with a representative of the transplant team.
6.2 If the patient decides to go forward for transplantation, he or she is then registered with UK Transplant and placed on the waiting list. If the patient is not deemed suitable and/or declines the option of transplantation the appropriate clinician will explain to the patient and their family the options available to them. The GP and referring clinicians should be informed of the outcome of the assessment.
7 THE WAITING LIST
7.1 The patient should receive detailed explanations, which are consistent, and key information pertaining to the waiting period for transplantation. This will be carried out according to each unit's protocols and practice.
7.2 During the waiting period the transplant unit will maintain contact with the patient and his/her family to offer support, information and guidance according to their needs. Clinical review of patients on the waiting list will be as clinically indicated.
REFERENCES
Addenbrookes NHS Hospital Waiting List for Kidney/Pancreas Transplant
Gruessner AC, Sutherland DE. (2000) Pancreas Transplant outcomes for United States cases reported to the United Network for Organ Sharing and non-US cases reported to the International Pancreas Transplant Registry as of October 2000, Clinical Transplant, October pp 45-72
Hakim N, Grey D, Stratta R J (2002) Pancreas and Islet Transplantation. Indications for Pancreas Transplantation, pp 60-71, Oxford University Press
Humar A, Ramcharan T, Kandaswamy R, Matas A, Gruessner RW, Gruessner AC, Sutherland DE. (2001) Pancreas after Kidney Transplants, American Journal Surgery 2001 Aug 182(2):155-61
Humar A, Sutherland DE, Ramcharan T, Gruessner R, Gruessner AC, Kandaswamy R (2000) Optimal Timing for a Pancreas Transplant after a successful Kidney Transplant, Transplantation Vol 70 No 8 pp 1247-1250
Koffman G (2002) Waiting List Criteria for Kidney/Pancreas Transplantation, UK Transplant Pancreas Task Force, minutes of June meeting, PTF (M)(02)1 pp3-4
Oxford Radcliffe NHS Hospital Criteria for Registration of patients for Kidney and Pancreas Transplantation
Pirsch JD, Andrews C, Hricik DE, Josephson MA, Leichtman AB, Lu CY, Melton LB, Rao VK, Riggio RR, Stratta RJ, Weir MR (1996) Pancreas Transplantation for Diabetes Mellitus, American Journal Kidney Disease Mar 27(3) pp 444-50
Sells R A, Taylor JD, Brown MW, Bakran A, Bone JM, Ahmad R (1995) Selection for low cardiovascular risk markedly improves patient and graft survival in Pancreaticorenal Transplant Recipients, Transplantation Proceedings Vol 27 No 6 pp 3082
Sutherland DE, Gruessner RW, Gruessner AC. 2001 Pancreas Transplantation for treatment of Diabetes Mellitus, World Journal Surgery Apr 25(4):487-96
The Royal Liverpool and Broadgreen University Hospital NHS Trust Protocol for Pancreaticorenal Transplantation