Evidence map›Paper›PMID 38960885›Full record

Trial reportJournal of gastric cancer2024

Morbidity and Mortality After Laparoscopy-Assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy to Treat Gastric Cancer: An Interim Report: A Phase III Multicenter, Prospective, Randomized Trial (The KLASS-07 Trial).

Han Hong Lee, Chang Min Lee, Moon-Soo Lee, In Ho Jeong, Myoung Won Son, Chang Hyun Kim, Moon-Won Yoo, Sung Jin Oh, Young-Gil Son, Sung Il Choi and 6 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Journal of gastric cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03393182 (A Multicenter Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopy-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric cancer_KLASS 07), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT03393182 nacompletednot on this map

A Multicenter Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopy-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric cancer_KLASS 07 (CKLASS01)(Korea-China Collaborated Study)

TypeinterventionalSponsorKorea University Anam HospitalRan2018 to 2022Enrolled443ConditionsQuality of Life, Gastric Cancer, Surgery, Surgical ComplicationArmsTLDG arm, LADG arm
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Han Hong LeeDivision of Gastrointestinal Surgery, Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID 0000-0002-7541-8490
Chang Min LeeDepartment of Surgery, Korea University College of Medicine, Seoul, Korea.ORCID 0000-0003-2567-5533
Moon-Soo LeeDepartment of Surgery, Eulji University Hospital, Daejeon, Korea.ORCID 0000-0002-3286-0385
In Ho JeongDepartment of Surgery, Jeju National University School of Medicine, Jeju, Korea.ORCID 0000-0002-0782-4542
Myoung Won SonDepartment of Surgery, Soonchunhyang University Hospital Cheonan, Cheonan, Korea.ORCID 0000-0001-5255-9234
Chang Hyun KimDepartment of Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID 0000-0003-1567-4318
Moon-Won YooDepartment of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID 0000-0003-0346-9042
Sung Jin OhDepartment of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.ORCID 0000-0002-2155-1376
Young-Gil SonDepartment of Surgery, Keimyung University Dongsan Medical Center, Daegu, Korea.ORCID 0000-0001-9088-6519
Sung Il ChoiDepartment of Surgery, Kyung Hee University Hospital at Gangdong, Seoul, Korea.ORCID 0000-0002-0662-0951
Mi Ran JungDepartment of Surgery, Chonnam National University Medical School, Hwasun, Korea.ORCID 0000-0002-4665-972X
Sang Hyuk SeoDepartment of Surgery, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.ORCID 0000-0002-7264-1339
Shin-Hoo ParkUijeongbu Eulji Medical Center, Eulji University College of Medicine, Uijeongbu, Korea.ORCID 0000-0001-9767-6100
Seong Ho HwangDepartment of Surgery, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID 0009-0008-7637-9519
Jae-Seok MinDepartment of Surgery, Korea University College of Medicine, Seoul, Korea.ORCID 0000-0002-5798-4595
Sungsoo ParkDepartment of Surgery, Korea University College of Medicine, Seoul, Korea.ORCID 0000-0002-1779-8683

Funding

Medtronic ERP 2017-10901NRF 2020R1A2C1012007
6 · The paper itself

Abstract

purposeWe conducted a randomized prospective trial (KLASS-07 trial) to compare laparoscopy-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer. In this interim report, we describe short-term results in terms of morbidity and mortality. METHODS AND

methodsThe sample size was 442 participants. At the time of the interim analysis, 314 patients were enrolled and randomized. After excluding patients who did not undergo planned surgeries, we performed a modified per-protocol analysis of 151 and 145 patients in the LADG and TLDG groups, respectively.

resultsThe baseline characteristics, including comorbidity status, did not differ between the LADG and TLDG groups. Blood loss was somewhat higher in the LADG group, but statistical significance was not attained (76.76±72.63 vs. 62.91±65.68 mL; P=0.087). Neither the required transfusion level nor the operation or reconstruction time differed between the 2 groups. The mini-laparotomy incision in the LADG group was significantly longer than the extended umbilical incision required for specimen removal in the TLDG group (4.79±0.82 vs. 3.89±0.83 cm; P<0.001). There were no between-group differences in the time to solid food intake, hospital stay, pain score, or complications within 30 days postoperatively. No mortality was observed in either group.

conclusionsShort-term morbidity and mortality rates did not differ between the LADG and TLDG groups. The KLASS-07 trial is currently underway.

trial registrationClinicalTrials.gov Identifier: NCT03393182.

Indexed as

GastrectomyLaparoscopyStomach NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedMorbidityPostoperative ComplicationsProspective StudiesGastrectomyLaparoscopyMorbidityMortalityStomach neoplasms

Identifiers

PMID38960885
PMCPMC11224718

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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.