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Complete Summary

GUIDELINE TITLE

Staging laparoscopy for primary hepatic tumors. In: Diagnostic laparoscopy guidelines.

BIBLIOGRAPHIC SOURCE(S)

  • Staging laparoscopy for primary hepatic tumors. In: Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Diagnostic laparoscopy guidelines. Los Angeles (CA): Society of American Gastrointestinal and Endoscopic Surgeons (SAGES); 2007 Nov. p. 47-50.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). SAGES guidelines for diagnostic laparoscopy. Los Angeles (CA): Society of American Gastrointestinal and Endoscopic Surgeons (SAGES); 2002 Mar. 5 p.

COMPLETE SUMMARY CONTENT

 
SCOPE
 METHODOLOGY - including Rating Scheme and Cost Analysis
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
 CONTRAINDICATIONS
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

Hepatocellular carcinoma (primary hepatic tumors)

GUIDELINE CATEGORY

Diagnosis
Evaluation

CLINICAL SPECIALTY

Gastroenterology
Oncology
Radiology
Surgery

INTENDED USERS

Physicians

GUIDELINE OBJECTIVE(S)

  • To assist surgeons' decisions about the appropriate use of staging laparoscopy in patients with hepatocellular carcinoma
  • To update the previous 2002 guidelines on this topic

TARGET POPULATION

Patients with primary hepatic tumors who are candidates for curative resection based on preoperative identification of size and location of disease with adequate hepatic reserve

INTERVENTIONS AND PRACTICES CONSIDERED

Staging laparoscopy in patients with hepatocellular carcinoma

MAJOR OUTCOMES CONSIDERED

  • Procedure-related/intraoperative complications
  • Procedure-related morbidity
  • Adverse oncologic effects
  • Postoperative hospital length of stay
  • Cost-effectiveness
  • Mortality

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

A systematic literature search of MEDLINE for the period 1995-2005 was limited to English language articles. The search strategy is shown in Figure 1 in the original guideline document. Using the same strategy, the Cochrane database of evidence-based reviews and the Database of Abstracts of Reviews of Effects (DARE) were searched.

Abstracts were reviewed by three committee members and into the following categories:

  • Randomized studies, meta-analyses, and systematic reviews
  • Prospective studies
  • Retrospective studies
  • Case reports
  • Review articles

Randomized controlled trials, meta-analyses, and systematic reviews were selected for further review along with prospective and retrospective studies that included at least 50 patients; studies with smaller samples were reviewed when other available evidence was lacking. The most recent reviews were also included. All case reports, old reviews, and smaller studies were excluded.

The reviewers graded the level of evidence of each article and manually searched the bibliographies for additional articles that may have been missed by the search. Any additional relevant articles were included in the review and grading.

NUMBER OF SOURCE DOCUMENTS

Not stated

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Levels of Evidence

Level I Evidence from properly conducted randomized, controlled trials
Level II Evidence from controlled trials without randomization

Or

Cohort of case-control studies

Or

Multiple time series, dramatic uncontrolled experiments
Level III Descriptive case series, opinions of expert panels

METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

To maximize the efficiency of the review, articles were divided into three subject categories:

  • Staging laparoscopy for cancer
  • Diagnostic laparoscopy for acute conditions
  • Diagnostic laparoscopy for chronic conditions

Reviewers graded the level of each article (see "Rating Scheme for the Strength of the Evidence.")

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The guidelines were developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and revised by the SAGES Guidelines Committee.

The statements included in this guideline are the product of a systematic review of published work on the topic, and the recommendations are explicitly linked to the supporting evidence. The strengths and weaknesses of the available evidence are described and expert opinion sought where the evidence is lacking. This is an update of previous guidelines on this topic (last revision 2002) as new information has accumulated.

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Scale Used for Recommendation Grading

Grade A Based on high-level (level I or II), well-performed studies with uniform interpretation and conclusions by the expert panel
Grade B Based on high-level, well-performed studies with varying interpretation and conclusions by the expert panel
Grade C Based on lower-level evidence (level II or less) with inconsistent findings and/or varying interpretations or conclusions by the expert panel

COST ANALYSIS

A 60% drop in hospital charges for patients undergoing staging laparoscopy compared with open laparotomy has been described.

METHOD OF GUIDELINE VALIDATION

Internal Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The recommendations of each guideline undergo multidisciplinary review and are considered valid at the time of production based on the data available. This statement was reviewed by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), November 2007.

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Definitions of the levels of evidence (I, II, III) and the grades of the recommendations (A, B, C) are provided at the end of the "Major Recommendations" field.

General Recommendations for Diagnostic Laparoscopy

Diagnostic laparoscopy is a safe and well tolerated procedure that can be performed in an inpatient or outpatient setting under general or occasionally local anesthesia with intravenous sedation in carefully selected patients. Diagnostic laparoscopy should be performed by physicians trained in laparoscopic techniques who can recognize and treat common complications and can perform additional therapeutic procedures when indicated. During the procedure, the patient should be continuously monitored, and resuscitation capability must be immediately available. Laparoscopy must be performed using sterile technique along with meticulous disinfection of the laparoscopic equipment. Overnight observation may be appropriate in some outpatients.

Staging Laparoscopy (SL) for Hepatocellular Carcinoma

Technique

The patient is placed in the supine position, and pneumoperitoneum is established. A 30-degree laparoscope through an umbilical port is recommended for optimal visualization of the entire liver. Additional ports can be placed in the right anterior axillary line and epigastric area as needed. A standard laparoscopic ultrasound probe is used to systematically examine the entire liver identifying all lesions suspected to be malignant. Ultrasound-guided core biopsy should be used for suspicious lesions that are unresectable or preclude curative resection. Biopsy of resectable lesions need not be performed.

Indications

Patients with primary hepatic tumors who are candidates for curative resection based on preoperative identification of size and location of disease with adequate hepatic reserve.

Recommendations

SL with laparoscopic ultrasound can be performed safely in patients with primary hepatic tumors (Grade B). Patients with primary hepatic cancers that appear resectable on preoperative imaging may benefit from SL with laparoscopic ultrasound to evaluate extent, location, and size of disease (Grade C). Selection criteria that may increase the yield and cost-effectiveness of the procedure are not currently available.

For details of the rationale for the procedure and its diagnostic accuracy, see the original guideline document.

Definitions:

Levels of Evidence

Level I Evidence from properly conducted randomized, controlled trials
Level II Evidence from controlled trials without randomization

Or

Cohort of case-control studies

Or

Multiple time series, dramatic uncontrolled experiments
Level III Descriptive case series, opinions of expert panels

Scale Used for Recommendation Grading

Grade A Based on high-level (level I or II), well-performed studies with uniform interpretation and conclusions by the expert panel
Grade B Based on high-level, well-performed studies with varying interpretation and conclusions by the expert panel
Grade C Based on lower-level evidence (level II or less) with inconsistent findings and/or varying interpretations or conclusions by the expert panel

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

The appropriate identification of patients who have unresectable disease by staging laparoscopy with laparoscopic ultrasound will potentially spare these patients a non therapeutic laparotomy with its associated morbidity and may alter treatment plans. Additional benefits include decreased patient morbidity, hospital stay and costs, and earlier time to adjuvant treatment.

POTENTIAL HARMS

  • Procedure- or anesthesia-related complications (see "Procedure-related Complications and Patient Outcomes" section in the original guideline document)
  • Unnecessary patient morbidity in cases of a low yield procedure
  • Potential adverse oncologic effects of the procedure
  • False negative examinations that lead to unnecessary laparotomy

CONTRAINDICATIONS

CONTRAINDICATIONS

Patients with known unresectable hepatic disease such as major vessel or organ invasion are not candidates for surgery. In addition, dense intra-abdominal adhesions, particularly surrounding the liver, from prior surgery may be considered a relative contraindication to SL and laparoscopic ultrasound.

QUALIFYING STATEMENTS

QUALIFYING STATEMENTS

Clinical practice guidelines are intended to indicate the best available approach to medical conditions as established by systematic review of available data and expert opinion. The approach suggested may not be the only acceptable approach given the complexity of the health care environment. These guidelines are intended to be flexible, as the surgeon must always choose the approach best suited to the patient and variables in existence at the time of the decision.

Limitations of the Available Literature

The quality and amount of the available literature for staging laparoscopy (SL) in primary hepatic tumors is limited, and no level I evidence exists. The designs of these studies differ. Some compare SL with laparoscopic ultrasound to preoperative imaging while others compare it to exploratory laparotomy. There is also inconsistency in the type of preoperative imaging and the specific computed tomography scan techniques used. In addition, the impact of each surgeon's expertise in laparoscopic ultrasound on the diagnostic accuracy of the procedure remains unknown. These limitations make firm recommendations difficult.

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

IMPLEMENTATION TOOLS

Foreign Language Translations
Patient Resources

For information about availability, see the "Availability of Companion Documents" and "Patient Resources" fields below.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Getting Better
Living with Illness

IOM DOMAIN

Effectiveness
Patient-centeredness
Safety

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Staging laparoscopy for primary hepatic tumors. In: Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Diagnostic laparoscopy guidelines. Los Angeles (CA): Society of American Gastrointestinal and Endoscopic Surgeons (SAGES); 2007 Nov. p. 47-50.

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

1998 Apr (revised 2007 Nov)

GUIDELINE DEVELOPER(S)

Society of American Gastrointestinal and Endoscopic Surgeons - Medical Specialty Society

SOURCE(S) OF FUNDING

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)

GUIDELINE COMMITTEE

Guidelines Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Not stated

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Members of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) disclose potential conflicts of interest and pertinent financial relationships prior to serving as faculty for SAGES-sponsored educational events, delivering presentations at scientific meetings, etc. Additionally, members of SAGES Committees disclose their potential conflicts of interest and pertinent financial relationships annually as a condition of committee membership.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). SAGES guidelines for diagnostic laparoscopy. Los Angeles (CA): Society of American Gastrointestinal and Endoscopic Surgeons (SAGES); 2002 Mar. 5 p.

GUIDELINE AVAILABILITY

Electronic copies: Available from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Web site.

Print copies: Available from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), 11300 W. Olympic Blvd., Suite 600, Los Angeles, CA 90064; Web site: www.sages.org.

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

The following is available:

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

This summary was completed by ECRI on November 19, 1999. The information was verified by the guideline developer on February 15, 2000. This summary was updated by ECRI on March 22, 2004. The information was verified by the guideline developer on April 27, 2004. This summary was updated by ECRI Institute on February 27, 2009. The updated information was verified by the guideline developer on March 9, 2009.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

NGC DISCLAIMER

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Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
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