EBM- Case Report

Supervisor：Dr.魏昌國

Presenter：Int.江元宏

2007. Aug. 10

Patient data

Name:謝○財

ID: Q100632702 Age: 56 years old

Sex: Male

ECOG: Gr. 1~2

Date of transfer : 2007/07/27

Date of operation: 2007/07/27

Chief complaint:

incidental finding of liver tumor for 1 month

Brief history

Under lying disease: DM, HTN.

2007. March: ESRD with CAPD;

Dx of HCV infection

2007. June.12: AFP-122ng/ml

� PE: No specific findings

� a series of image studies

Non-Contrast CT

Contrast CT- Arterial phase

Contrast CT- Portal venous phase

Contrast CT- Venous phase

Angiography

Diagnosis: HCC over S7~8 (2.5cm nodule)

Operation: S7-8 segmentectomy on 7/27

Clinical problem:

Does ESRD affect the outcome (surgical morbidity, mortality and long-term survival ) of patient with HCC treated with hepatectomy?

The Structure of The Question

Patient / Problem Patient with HCC treated with liver resection

Exposure (prognostic/ risk factors)

Status with ESRD

Comparison (control) Status without ESRD

Outcome Morbidity and mortality rates

after surgery, long-term survival rate

Key words:

Hepatocellular carcinoma, HCC

End stage renal disease, chronic renal failure,

=> (Hepatocellular carcinoma OR HCC) AND (End stage renal disease OR chronic renal failure)

Screen Results:

A

B

Methods and PopulationsRetrospective study

1982 to 2001,

1224 consecutive HCC p’ts under surgeryy

at the Department of Surgery, CGMH, Taipei, Taiwan.

26 of 1224 (2.1%): ESRD-HCC (25 HD, 1 PD)

1198 of 1224 (97.9%): HCC only

67 of 1198 (HCC group) : loss of follow-up (excluded from

survival analysis)

All other 1157 p’ts（1224 -67）were followed regularly until death.

Retrospective study

1989 to 1999

468 patients with primary HCC who had undergone curative liver resection for HCC

12 of 468 (2.6%): ESRD-HCC (12 HD)

456 of 468 (97.4%): HCC only

All patients were followed-up until December 2000

A B

Data collectionPre-OP:

- Demographics

- Symptomatology

- Physical examination

- Laboratory data

- Presence of cirrhosis

OP findings and extent of resections

Post-OP:

- Pathological features

- morbidity

- surgical mortality

- long-term survival rate

- long-term disease free survival rate

Pre-OP:

- Demographics

- Laboratory data

- Presence of cirrhosis

OP findings and extent of resections

- the process of OP

Post-OP:

- Pathological features

- morbidity

- surgical mortality

- long-term survival rate

- long-term disease free survival rate

A B

Results: DemographicsA

Results: lab. dataA

Results: (OP, Pathology, Post-OP complication)A

Results AnalysisA

Univariate analysis：ESRD-HCC:↑ associated disease (HTN, DM)

↑ physical signs of anemia,

↓ HBV positivity, ↑HCV positivity,

↓ Hb and PLT, ↑ BUN, Cre

↓ AFP(>400ng/ml) levels,↓ tumor size,

↑ complications, and ↑ stay at hospital

Multivariate logistic regression analysis：elevated BUN and Cre were the only two independent factors differentiating ESRD-HCC from HCC

Results: long-term follow-upA

n=1131

n=1131

All the 1157 p’ts（1224 - 67）were followed regularly until death.

Duration of follow-up：：：：26 ESRD-HCC：0.01 to 97.6 mo (median = 15.0 mo)1131 HCC： 0.01 to 213.5 mo (median = 14.6 mo)

Overall survival rates (OS):ESRD-HCC：1-, 3-, and 5-years: 82.0%, 38.1%, 38.1%HCC： 1-, 3-, and 5-year: 70.6%, 48.6%, 34.8%P= 0.7034

Disease-free survival rates (DFS):ESRD-HCC： 1-, 3-, and 5-years: 63.1%, 49.1%, 16.4%HCC： 1-, 3-, and 5-years: 55.2%, 35.4%, 26.9%P=0.6123

Results: long-term follow-upA

Elevated BUN and Cre values were the only two independent factors differentiating ESRD-HCC from HCC patients

ESRD should not be a contraindication of hepatic resection in HCC patients; however, careful operative techniques and perioperative care are crucial to

achieving lower morbidity and mortality.

The long-term results of HCC patients with and without

ESRD were also not significantly different

Summary:A

ResultsB

A+

A+A+

A-

ResultsB

A+

A+

A-

ResultsB A-

ResultsB A-

ResultsB

P=0.54

P=0.31

All patients were followed-up until December 2000

Disease-free survival rates (DFS):ESRD-HCC： 5-years: 67.8%

HCC：5-year: 53.3%

P=0.31

Overall survival rates (OS):ESRD-HCC： 5-years: 35%

HCC：5-year: 34.2%

P= 0.54

Results: long-term follow-upB

Background and pathologic character: similar in both group, except Hb and Cre

The long-term results of HCC patients with and without

ESRD were also not significantly different

SummaryB

EBM Analysis

Source population well described?

Eligible population well described?

Participants represents of eligibles?

Eligible population at common point in

course of condition (stage of condition)?

Were relevant personal (prognostic)

characteristics in participants reported?

Population~ Representative

~

x

x

x

~

x

x

x

x

A B

~

EBM Analysis

Exposure and comparison measures well described and valid?

Were exposure & comparison groups similar at baseline? Appropriately adjusted?

Were exposure / comparison status

change during follow-up?

All participants accounted for at study

conclusion?

Exposure & Comparison~

~

~

x

x

A B

~

~

x

x

++

EBM Analysis

Outcome measures well described & valid?

Outcome assessment blind?

Outcome measurement complete?

Outcomes~ Measured well

x

~

A B

+

x

+

-

EBM Analysis

Similar follow-up time in exposure & comparison groups?

Was follow-up time meaningful?

Intention to follow analysis?

(Effect) estimates given or calculable?

(Precision of effect) estimates given or

calculable?

Time

+

A B

x

~

~

Results

~

A B

+

~

x

~ ~

EBM Analysis

Internal vaild?

Are results precise enough to be

meaningful?

External valid? (applicability)

Summary~

~

+

-

~

~

-

A B

Big Problem

My Conclusion

Population continues to be the big problem in

the future.

Until know, there was no other more evidence

study.

Although there were many poor EBM levels in

these 2 studies, they could render a hint or

reference to our clinical practice.

Thanks for your attention！

★

★

Comment

Dr.李宜恭：所以你認為這兩篇Journal最大的問題在於?

Ans: 最大的問題在於選取的樣本數未清楚交代，易產生selection bias

Dr.李宜恭：你的結論跟想法?

Ans: 基本上這兩篇的evidence層面都不是很強，但是已經是目前發表出來最大型且最高證據強度的文章，因此我的看法是”目前來看，沒有答案，但是對於surgeron的角度來看，臨床上目前沒有證據認為這是不好的prognostic factor”

Dr.尹文耀：這篇文章的確以EBM角度來看，不足以成為practice guideline，但是他在臨床上可以”encourage”外科醫師去幫這類病人開刀，才不會使得有些curable的patient因為ESRD而沒有被適當處置。