Evidence map›Paper›PMID 34961558›Full record

ArticleTrials2021

Robotic versus Open Pancreatoduodenectomy for Pancreatic and Periampullary Tumors (PORTAL): a study protocol for a multicenter phase III non-inferiority randomized controlled trial.

Jiabin Jin, Yusheng Shi, Mengmin Chen, Jianfeng Qian, Kai Qin, Zhen Wang, Wei Chen, Weiwei Jin, Fengchun Lu, Zheyong Li and 14 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04400357 (Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 7% 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.

NCT04400357 nacompletednot on this map

Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors: A Multicenter Phase III Non-Inferiority Randomized Controlled Trial

TypeinterventionalSponsorRuijin HospitalRan2020 to 2025Enrolled268ConditionsPancreatic Adenocarcinoma, Pancreatic Cysts, Pancreatic Endocrine Tumors, Chronic PancreatitisArmsRobotic pancreaticoduodenectomy, Open pancreaticoduodenectomy
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Observational
  7. Review
  8. Article
  9. Article
  10. Robotic pancreatoduodenectomy: an ongoing exploration.The Lancet regional health. Europe · 2024
    Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Impact of Neoadjuvant Treatment and Minimally Invasive Surgery on Perioperative Outcomes of Pancreatoduodenectomy: an ACS NSQIP Analysis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2023
    Article
  16. 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

24 authors at 8 institutions in 2 countries.

Jiabin Jin *Department of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Yusheng Shi *Department of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Mengmin Chen *Department of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Jianfeng Qian *Department of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Kai Qin *Department of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Zhen WangDepartment of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi Province, China.
Wei ChenDepartment of Pancreaticobiliary Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China.
Weiwei JinDepartment of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang Province, China.
Fengchun LuDepartment of General Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.
Zheyong LiDepartment of General Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.
Zehua WuDepartment of Hepatobiliary and Pancreatic Surgery, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China.
Li JianClinical Research Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Bing HanDepartment of Hepatobiliary and Pancreatic Surgery, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China.
Xiao LiangDepartment of General Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.
Chuandong SunDepartment of Hepatobiliary and Pancreatic Surgery, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China.
Zheng WuDepartment of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi Province, China.
Yiping MouDepartment of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang Province, China.
Xiaoyu YinDepartment of Pancreaticobiliary Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China.
Heguang HuangDepartment of General Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.
Hao ChenDepartment of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Georgios GemenetzisDepartment of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. georgios.gemenetzis@glasgow.ac.uk.ORCID http://orcid.org/0000-0002-0549-1369
Xiaxing DengDepartment of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. kejiadxx@hotmail.com.
Chenghong PengDepartment of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. chhpeng@yeah.net.
Baiyong ShenDepartment of Pancreatic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. shenby@shsmu.edu.cn.
Shanghai Jiao Tong University · CNQingdao University · CNFujian Medical University · CNSir Run Run Shaw Hospital · CNSun Yat-sen University · CNZhejiang Provincial People's Hospital · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CNGlasgow Royal Infirmary · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPancreatoduodenectomy is a complex and challenging procedure that requires meticulous tissue dissection and proficient suturing skills. Minimally invasive surgery with the utilization of robotic platforms has demonstrated advantages in perioperative patient outcomes in retrospective studies. The development of robotic pancreatoduodenectomy (RPD) in specific has progressed significantly, since first reported in 2003, and high-volume centers in pancreatic surgery are reporting large patient series with improved pain management and reduced length of stay. However, prospective studies to assess objectively the feasibility and safety of RPD compared to open pancreatoduodenectomy (OPD) are currently lacking. METHODS/

designThe PORTAL trial is a multicenter randomized controlled, patient-blinded, parallel-group, phase III non-inferiority trial performed in seven high-volume centers for pancreatic and robotic surgery in China (> 20 RPD and > 100 OPD annually in each participating center). The trial is designed to enroll and randomly assign 244 patients with an indication for elective pancreatoduodenectomy for malignant periampullary and pancreatic lesions, as well as premalignant and symptomatic benign periampullary and pancreatic disease. The primary outcome is time to functional recovery postoperatively, measured in days. Secondary outcomes include postoperative morbidity and mortality, as well as perioperative costs. A sub-cohort of 128 patients with pancreatic adenocarcinoma (PDAC) will also be compared to assess the percentage of patients who undergo postoperative adjuvant chemotherapy within 8 weeks, in each arm. Secondary outcomes in this cohort will include patterns of disease recurrence, recurrence-free survival, and overall survival. DISCUSSION: The PORTAL trial is designed to assess the feasibility and safety of RPD compared to OPD, in terms of functional recovery as described previously. Additionally, this trial will explore whether RPD allows increased access to postoperative adjuvant chemotherapy, in a sub-cohort of patients with PDAC.

trial registrationClinicalTrials.gov NCT04400357 . Registered on May 22, 2020.

Indexed as

AdenocarcinomaPancreatic NeoplasmsRobotic Surgical ProceduresEquivalence Trials as TopicHumansMulticenter Studies as TopicNeoplasm Recurrence, LocalPancreaticoduodenectomyPostoperative ComplicationsProspective StudiesRandomized Controlled Trials as TopicRetrospective StudiesTreatment OutcomeMinimally invasiveOutcomesPancreatic cancerPancreatoduodenectomyRecurrenceRobot-assistedRoboticSurvivalWhipple

Identifiers

PMID34961558
PMCPMC8711152
OpenAlexW4200491613

What OpenQuestion holds

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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.