Evidence map›Paper›PMID 10235519›Full record

Trial reportAnnals of surgery1999

Pancreaticoduodenectomy with or without extended retroperitoneal lymphadenectomy for periampullary adenocarcinoma: comparison of morbidity and mortality and short-term outcome.

C J Yeo, J L Cameron, T A Sohn, J Coleman, P K Sauter, R H Hruban, H A Pitt, K D Lillemoe

Registry-linked trialOpen access · greenAbstract readClinical TrialComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of surgery, 1999. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00679913 (Randomized Controlled Study), which is not on this map. Cited by 117 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
117citing papers in PubMed, 12 pooled it
6.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00679913 phase3completednot on this mapstarted 2005, after this paper: background citation

Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy

TypeinterventionalSponsorSeoul National University HospitalRan2005 to 2013Enrolled244ConditionsPancreatic CancerArmsStandard pancreatoduodenectomy, Extended pancreatoduodenectomy
3 · Its place in the literature

Who cites it

117 citing papers in PubMed, 12 syntheses or guidelines pooled it, 363 citations in OpenAlex.

  1. Pooled it
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  4. Extended Versus Standard Lymphadenectomy for Pancreatic Head Cancer: Meta-Analysis of Randomized Controlled Trials.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2015
    Pooled it
  5. A meta-analysis of extended versus standard lymphadenectomy in patients undergoing pancreatoduodenectomy for pancreatic adenocarcinoma.HPB : the official journal of the International Hepato Pancreato Biliary Association · 2015
    Pooled it
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  9. Pancreatic adenocarcinoma.Journal of the National Comprehensive Cancer Network : JNCCN · 2010
    Guideline
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  17. Enteral nutrition and biliopancreatic diversion effectively minimize impacts of gastroparesis after pancreaticoduodenectomy.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2009
    Trial
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57 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

C J YeoDepartment of Surgery, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
J L Cameron
T A Sohn
J Coleman
P K Sauter
R H Hruban
H A Pitt
K D Lillemoe
Johns Hopkins University · US

Funding

Tumor Antigens for Individual Signatures and TherapyP50CA062924 · NCI · JOHNS HOPKINS UNIVERSITY · PI LENNON, ANNE MARIE · 1993 to 2022
$54.6M
CORRELATES AND TREATMENT OF PANCREATIC CARCINOMAR01CA056130 · NCI · JOHNS HOPKINS UNIVERSITY · PI YEO, CHARLES J · 1991 to 1993
–
NCI NIH HHS P50 CA062924NCI NIH HHS P50-CA62924NCI NIH HHS R01-CA56130
6 · The paper itself

Abstract

objectiveThis prospective, randomized, single-institution trial was designed to evaluate the end points of mortality, morbidity, and survival in patients undergoing standard versus radical (extended) pancreaticoduodenectomy (including distal gastrectomy and retroperitoneal lymphadenectomy). SUMMARY BACKGROUND DATA: Numerous retrospective reports and one prospective randomized trial have suggested that the performance of an extended lymphadenectomy in association with a pancreaticoduodenal resection may improve long-term survival for some patients with pancreatic and other periampullary adenocarcinomas. Many of these previously published studies can be criticized for their retrospective and nonrandomized designs, for the inclusion of nonconcurrent control groups, and for their small numbers.

methodsBetween April 1996 and December 1997, 114 patients with periampullary adenocarcinoma were enrolled in an ongoing, prospective, randomized trial at The Johns Hopkins Hospital. After intraoperative verification of completely resected periampullary adenocarcinoma, the patients were randomized to receive either a standard pancreaticoduodenectomy (removing only the peripancreatic lymph nodes en bloc with the specimen) or a radical pancreaticoduodenectomy (standard resection plus distal gastrectomy and retroperitoneal lymphadenectomy). All pathology specimens were reviewed and categorized. The postoperative morbidity, mortality, and short-term outcomes were examined.

resultsOf the 114 patients randomized, 56 underwent a standard pancreaticoduodenectomy and 58 a radical pancreaticoduodenectomy. The two groups were statistically similar with regard to age and gender, but there was a higher percentage of white patients in the radical group. All the patients in the radical group underwent distal gastric resection, whereas 86% of the patients in the standard group underwent pylorus preservation. The mean operative time in the radical group was 6.8 hours, compared with 6.2 hours in the standard group. There were no significant differences between the two groups with respect to the intraoperative blood loss, transfusion requirements, location of primary tumor, mean tumor size, positive lymph node status, or positive margin status. There were three deaths in the standard group and two in the radical group. The complication rates were 34% for the standard group and 40% for the radical group. Patients undergoing radical resection had a higher incidence of early delayed gastric emptying but had similar rates of other complications, such as pancreatic fistula, wound infection, intraabdominal abscess, and need for reoperation. The mean total number of lymph nodes resected was higher in the radical group. Of the 58 patients in the radical group, only 10% had metastatic carcinoma in the resected retroperitoneal lymph nodes, and none of those patients had the retroperitoneal nodes as the only site of lymph node involvement. The 1-year actuarial survival rate for patients surviving the immediate postoperative periods was 77% for the standard resection group and 83% for the radical resection group.

conclusionsThese data demonstrate that radical pancreaticoduodenectomy (with the addition of a distal gastrectomy and extended retroperitoneal lymphadenectomy to a standard pancreaticoduodenectomy) can be performed with similar morbidity and mortality to standard pancreaticoduodenectomy. However, the survival data are not sufficiently mature and the numbers of patients enrolled are not adequate to allow firm conclusions to be drawn regarding survival benefit.

Indexed as

Ampulla of VaterAdenocarcinomaAgedCommon Bile Duct NeoplasmsFemaleHumansLymphatic MetastasisLymph Node ExcisionMalePancreaticoduodenectomyPostoperative CarePostoperative ComplicationsProspective StudiesRetroperitoneal SpaceSurvival RateTime Factors

Identifiers

PMID10235519
PMCPMC1420805
OpenAlexW2022866903

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.