Method: We conducted search of relevant articles using PubMed search engine to answer the clinical
EVIDENCE - BASED CASE REPORT
(QGRVFRSLF 'LODWDWLRQ YHUVXV 2HVRSKDJHDO
6WHQW LQ %HQLJQ 2HVRSKDJHDO 6WULFWXUH
Hadyanto Caputra*, Iqbal I Awang*, Pringgodigdo Nugroho**, Ari Fahrial Syam***
- Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo General National Hospital, Jakarta **Division of Renal-hypertension, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia/ Dr. Cipto Mangunkusumo General National Hospital, Jakarta ***Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia/ Dr. Cipto Mangunkusumo General National Hospital, Jakarta
Corresponding author:
Ari Fahrial Syam. Division of Gastroenterology, Department of Internal Medicine, Dr. Cipto Mangunkusumo
General National Hospital. Jl. Diponegoro No.71 Jakarta Indonesia. Phone: +62-21-3153957;
Facsimile: +62-21-3142454. E-mail: ari_syam@hotmail.com $%675$&7Aim: Oesophageal stricture is one of the causes of dysphagia. It is a condition in which the lumen of
RHVRSKDJXV LV QDUURZHG E\ ¿EURWLF WLVVXH LQ WKH RHVRSKDJHDO ZDOO ,W LV XVXDOO\ FDXVHG E\ LQÀDPPDWLRQ RU
any other cause that leads to necrotizing of tissue. It is mainly differentiated into benign or malignant. The aim
of this article is to answer the clinical question on the effectiveness of oesophageal stenting compared to
endoscopic dilatation in patient with benign oesophageal stricture due to ingestion of corrosive substances,
who had undergone several endoscopic dilatations.Method: We conducted search of relevant articles using PubMed search engine to answer the clinical
question. Keywords being used during the search process were: ("oesophageal stricture"[All Fields]
OR "oesophageal stenosis"[All Fields] AND (("dilatation"[All Fields] AND ("stents"[MeSH Terms] OR
VWHQWV >$OO )LHOGV@ 25 VWHQW >$OO )LHOGV@ 5HVXOWV ZHUH IXUWKHU FRQYHUJHG E\ DGGLQJ VSHFL¿F ¿OWHUV ZKLFK
were full text articles and clinical trial.Results: The chosen article was further appraised in order to identify its validity and eligibility to answer
the clinical question. We chose to use CONSORT (statement to improve the quality of reporting of RCTs)
to facilitate the critical appraisal and interpretation of RCTs.Conclusion: Stenting was associated with greater dysphagia, co-medication and adverse events. No
randomized controlled trials which compared biodegradable stents with other stents or with balloon
GLODWDWLRQ ZDV LGHQWL¿HG /DFN RI DGHTXDWHO\ UREXVW HYLGHQFH IRU HIIHFWLYHQHVV DQG FRVW HIIHFWLYHQHVV IRUPHG
the rationale of this trial.Keywords: benign oesophageal stricture, endoscopic dilatation, stent $%675$. Tujuan: Striktur esofagus merupakan salah satu penyebab disfagia. Striktur esofagus adalah suatu kondisi
GL PDQD OXPHQ HVRIDJXV PHQ\HPSLW NDUHQD DGDQ\D MDULQJDQ ¿EURVLV SDGD GLQGLQJ HVRIDJXV +DO LQL ELDVDQ\D
GLVHEDENDQ ROHK LQÀDPDVL DWDX SHQ\HEDE ODLQ \DQJ VHODQMXWQ\D GDSDW PHUDQJVDQJ MDULQJDQ XQWXN PHQJDODPL
nekrosis. Secara umum, striktur esofagus dibagi menjadi dua, yaitu jinak dan ganas. Tujuan artikel ini adalah untuk
menjawab pertanyaan klinis tentang efektivitas sten esofagus dibandingan dengan dilatasi endoskopi pada pasien
dengan striktur esofagus jinak akibat menelan zat korosif dan telah menjalani dilatasi endoskopi beberapa kali. Hadyanto Caputra, Iqbal I Awang, Pringgodigdo Nugroho, Ari Fahrial Syam Metode: Kami melakukan pencarian artikel yang relevan dengan menggunakan alat pencarian PubMed
untuk menjawab pertanyaan klinis tersebut. Kata kunci yang kami gunakan pada proses pencarian adalah:
("oesophageal stricture"[All Fields] OR "oesophageal stenosis"[All Fields] AND (("dilatation"[All
Fields] AND ("stents"[MeSH Terms] OR "stents"[All Fields] OR "stent"[All Fields]). Kemudian, pada hasil
SHQFDULDQ NDPL PHQDPEDKNDQ ¿OWHU IXOO WH[W DUWLFOHV GDQ FOLQLFDO WULDOHasil: Artikel yang terpilih selanjutnya ditelaah untuk mengevalusi validitas dan kesesuaiannya untuk
menjawab pertanyaan klinis tersebut. Kami memilih metode CONSORT (pernyataan untuk meningkatkan
kualitas pelaporan uji kontrol acak) untuk membantu menelaah dan menafsirkan uji kontrol acak secara kritis.
Kata kunci: striktur esofagus jinak, dilatasi endoskopik, stent ,1752'8&7,21
Esophageal stricture is one of the cause of G\VSKDJLD ZKLFK LV D VXEMHFWLYH VHQVDWLRQ RI RUJDQLF abnormality during the process of food or liquid passing from the oral cavity to stomach. It varies from unable to swallow (oropharingeal dysphagia) to sensation of obstruction while food passing the oesphagus to stomach (esophageal dysphagia).
Esophageal stricture is a condition which the lumen RI HVRSKDJXV QDUURZHG E\ ¿EURWLF LQ WKH HVRSKDJHDO wall. Usually due to inflamation and any other causes that lead to necrotizing of tissue. 1 Esophageal stricture is differentiated into benign or malignant.
WUDFW LQ SDWLHQWV ,W ZDV IRXQG WKDW
The later usually caused by malignancy or cancer
LQ HVRSKDJXV FRXOG EH LQWUDOXPHQ RU H[WUDOXPHQ
And the first may caused by gastro esophageal UHÀX[ GLVHDVH *(5' FRUURVLYH VXEVWDQFH DIWHU DQDVWRPRVHV RI HVRSKDJXV DIWHU UDGLRWKHUDSK\ DQG chronic esophagitis. Esophageal trauma caused by corrosive substance may lead to stricture. Stricture that caused by corrosive substance should be monitored periodically that recurrent of the sticture might happened. Ingestion of corrosive substances remain an important public health issue in Western countries despite education and regulatory efforts to reduce its occurrence. These injuries are still LQFUHDVLQJ LQ GHYHORSLQJ FRXQWULHV UHODWHG WR WKH
Simpulan: Pemasangan stent berhubungan dengan memberatnya gejala disfagia, penggunaan lebih dari
satu obat, dan timbulnya efek samping. Tidak ditemukan adanya uji kontrol acak yang membandingkan stent
dengan stent lain atau dilatasi balon. Kurangnya bukti kuat mengenai efektivitas dan kendali biaya merupakan
dasar dilakukannya pencarian ini.LQ VRPH GHYHORSLQJ FRXQWULHV OLNH ,QGLD ZKHUH hydrochloric acid and sulfuric acid are easily accessible. Acids and alkalis produce different types RI WLVVXH GDPDJH $FLGV FDXVH FRDJXODWLRQ QHFURVLV with eschar formation that may limit substance penetration
DQG LQMXU\ GHSWK &RQYHUVHO\ DONDOLV combine with tissue proteins and cause liquefactive QHFURVLV DQG VDSRQL¿FDWLRQ DQG SHQHWUDWH GHHSHU LQWR WLVVXHV KHOSHG E\ D KLJKHU YLVFRVLW\ DQG D longer contact time through the esophagus. In &LSWR 0DQJXQNXVXPR KRVSLWDO FRQGXFWHG endoscopic examination of upper gastrointestinal
RI WKHP ZHUH IRXQG D VROLG WXPRU GXH WR FRUURVLYH VXEVWDQFH DQG LQ SDWLHQWV after sclerotherapy of esopahageal varices Several modalities to treat the stricture such as dilatation
RI HVRSKDJXV LQWUD OHVVLRQ FRUWLFRVWHURLG LQMHFWLRQ
IRRGV ZKLFK PD\ UHVXOW LQ PDOQXWULWLRQ DVSLUDWLRQ and weight loss. Strictures are conventionally treated by endoscopic dilatation using either a balloon (radially dilating the stricture) or a bougie (dilating the stricture by shearing longitudinal force). The placement of self-expanding metallic stents is routinely used to maintain esophageal patency in patients with malignancy that either have non-resectable disease or are poor candidates
SODFLQJ VWHQW VWULFWXURSODVW\ DQG UHVHFWLRQ RI WKH stricture. Choosing treatment modality should FRQVLGHU VHYHUDO WKLQJV DQG FRQGLWLRQ DQG GLIIHU IURP one patient to another. The main goal is to recover the function of esophagus as a passage way and swallowing process. 6 Benign oesophageal strictures (narrowing of the oesophagus) present with dysphagia of solid or liquid
VRFLDO HFRQRPLF DQG HGXFDWLRQDO YDULDEOHV DQG mainly to a lack of prevention. The problem is largely unreported in these settings and its true prevalence simply cannot be extrapolated from the scarce papers or personal experience.
7UDGLWLRQDOO\ LQJHVWHG FRUURVLYH VXEVWDQFHV DUH either alkalis or acids. Alkaline material accounts for most caustic ingestions in Western countries whereas injuries from acid are more common
Endoscopic Dilatation versus Oesophageal Stent in Benign Oesophageal Stricture
for surgery. Many reports have documented the
VWLOO EHLQJ D FKRLFH IRU WUHDWLQJ WKH VWULFWXUH RU LV LW necessary to place a stent to prevent recurrent stenosis FOLQLFDO HIIHFWLYHQHVV RI WKHVH WRROV SDUWLFXODUO\ FRYHUHG PHWDOOLF VWHQWV +RZHYHU WKH XVHIXOQHVV RI RU VWULFWXUH LQVWHDG RI UHSHDWHGO\ GLODWLQJ WKH VWHQRVLV metallic stents for benign stenosis is limited due to through endoscopy in a benign oesophageal strictures. relatively little information regarding their long-term FRPSOLFDWLRQV LQFOXGLQJ PLJUDWLRQ WKH IRUPDWLRQ
0(7+2'
RI QHZ VWULFWXUHV ¿VWXOD IRUPDWLRQ DQG K\SHUSODVWLF tissue reactions. Since the cause of benign ,Q RUGHU WR DQVZHU WKH TXHVWLRQ ZH FRQGXFW esophageal stenosis does not directly affect the searching in PubMed for evidences in studies or clinical trials that has high correlation and answer the
SDWLHQWV¶ SURJQRVLV LW LV PRUH LPSRUWDQW WR SUHYHQW the incidence of long-term complications. It is highly question. We used several keywords with bollean OR desirable to develop a stent that could be kept in
RU DQG $1' 7KHVH DUH WKH NH\ZRUGV WKDW EHLQJ XVHG for searching the articles: ("oesophageal stricture"[All WKH SURSHU SRVLWLRQ GXULQJ WKH UHSDLU SURFHVV DQG
Fields] OR "esophageal stenosis"[All Fields] AND WKHQ EH HDVLO\ UHPRYHG WKXV DYRLGLQJ UH VWHQRVLV
(("dilatation"[All Fields] AND ("stents"[MeSH ,Q RWKHU ZRUGV LI D VWHQW FRXOG EH FRQVWUXFWHG
Terms] OR "stents"[All Fields] OR "stent"[All
IURP D ELRGHJUDGDEOH PDWHULDO WKHQ D VXEVHTXHQW stent removal operation would not be necessary.
)LHOGV@ 7KH UHVXOW VKRZV DUWLFOHV LQ DQ\ NLQG The degradable nature of the stent would prevent RI VWXGLHV :H ¿OWHU WKH DUWLFOHV ZKLFK DUH IXOO WH[W serious long-term complications. articles. Then the articles converge into 16 articles.
7KH TXHVWLRQ LV when a person had underwent dilatation for several :H ZDQW WR FRPSDUH EHWZHHQ PRGDOLWLHV RI WKHUDS\ VR
WLPHV WR WUHDW WKH VWULFWXUH LV LW QHFHVVDU\ WR FKDQJH WKH ZH VKRXOG ¿QG DUWLFOHV WKDW WKH W\SH RI VWXG\ VXLWDEOH modality of mid or long term treatment such as placing to answer the question. The proper type of study stent in the stricture to prevent recurrent stenosis.
VKRXOG EH D FOLQLFDO WULDO 6R WKHQ ZH ¿OWHUL]HG WKH
2U LV GLODWDWLRQ VWLOO EHLQJ D FKRLFH RI WUHDWPHQW IRU WKH VWHQRVLV DOWKRXJK LW ZRXOG EH GRQH UHSHDWHGO\ LQ Keywords: several months? Fields] AND (("dilatation"[All Fields] AND ("stents"[MeSH Terms] "oesophageal stricture"[All Fields] OR "esophageal stenosis"[All OR "stents"[All Fields] OR "stent"[All Fields]
&/,1,&$/ 48(67,21
3DWLHQW LV D PDOH \HDUV ROG ZDV KRVSLWDOL]HG due to hematemesis and melena. It started when he had given a drink by his friend while working. He
IHOW WKDW WKH WDVWH RI FDUERQL]HG GULQN YHU\ XQXVXDO Result: found 125 articles but he kept swallow it about half of bottle. About KRXUV ODWHU ZKLOH KH ZDV DW KRPH DOO RI VXGGHQ KH KDG D SURMHFWLOH YRPLW ZKLFK FRQVLVW RI EORRG full text Filter: DERXW WLPHV +H IHOW WKDW KLV WKURDW OLNH EHLQJ EXUQHG Than he fell out and administered to the hospital. He was diagnosed having a esophageal stricture due to Result: found 16 articles
FRUURVLYH VXEVWDQFH %HIRUH KH GUDQN WKH VRGD KH
VPHOW VRPH NLQG RI FKHPLFDO RI ÀRRU FOHDQHU Clinical Trial Filter: He had underwent several endoscopic dilation with
EDOORRQ DERXW PRQWKV GXH WR UHSHDWHG VWULFWXUH WKDW Result: found 1 article PDGH KLP QRW EH DEOH WR HDW HYHQ WR GULQN +H VKRXOG drink small amount of water to get it swallowed. He ask wether there is a way that he would not take dilation often. Other option is placing stent which can dilate the lumen
IRU ORQJHU SHULRG LQVWHDG RI VKRUW WHUP UHSHDWHG GLODWLRQ ,Q WKLV SDSHU RI (%&5 ZH VKRXOG ¿QG WKH DQVZHU
RI WKH TXHVWLRQ PHQWLRQHG EHIRUH ZHWKHU GLODWDWLRQ )LJXUH )UDPHZRUN DQG FRQFHSW RI VHDUFKLQJ DUWLFOHV
7 Eligibility criteria for participants and the settings and locations where the data were collected.
5
13
14
15
16
17
18
19 Flow of participants through each stage (a diagram is strongly UHFRPPHQGHG 6SHFL¿FDOO\ IRU HDFK JURXS UHSRUW WKH QXPEHUV RI participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome. Describe protocol deviations from study as planned, together with reasons.
'DWHV GH¿QLQJ WKH SHULRGV RI UHFUXLWPHQW DQG IROORZ XS Baseline demographic and clinical characteristics of each group Number of participants (denominator) in each group induded in each analysis and whether the analysis was by “intention to treat.” State the results in absolute numbers when feasible (e.g., 10 of 20, not 50%). For each primary and secondary outcome, a summary of results for each JURXS DQG WKH HVWLPDWHG HIIHFWV VL]H DQG LWV SUHFLVLRQ H J FRQ¿GHQFH interval). Address multiplicity by reporting any other analyses performed, including
VXEJURXS DQDO\VHV DQG DGMXVWHG DQDO\VHV LQGLFDWLQJ WKRVH SUHVSHFL¿HG DQG those exploratory All important adverse events or side effects in each intervention group
4
4
4
3 Results
4
6
7 Discussion Interpretation Generalizability Overall evidence
20
21
22 Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision, and the dangers associated with multiplicity of analyses and outcomes
5
7
7
search method by adding “clinical trial” in advance search. The result leads to one article that can answer WKH TXHVWLRQ WLWOHG ³%LRGHJUDGDEOH VWHQW RU EDOORRQ dilatation for benign oesophageal stricture: Pilot UDQGRPLVHG FRQWUROOHG WULDO´ E\ 'KDU $ HW DO ZKLFK published in World Journal of Gastroenterology in th 'HFHPEHU 7KH IUDPHZRUN DQG FRQFHSW RI VHDUFKLQJ LV LOOXVWUDWHG LQ ¿JXUH
5(68/76
The choosen article should be appraised in order to see wether it has good validity and eligible to answer the question. A group of scientists and editors quality of reporting of RCTs. The statement consists RI D FKHFNOLVW DQG ÀRZ GLDJUDP WKDW DXWKRUV FDQ XVH IRU
3DUWLFLSDQW ÀRZ Recruitment Baseline data Numbers analyzed Outcomes and estimation Anciliary analyses Adverse events
3
Hadyanto Caputra, Iqbal I Awang, Pringgodigdo Nugroho, Ari Fahrial Syam )LJXUH &KHFNOLVW RI LWHP LQ UHSRUWLQJ D UDQGRPL]HG WULDO &216257
6SHFL¿F REMHFWLYHV DQG K\SRWKHVHV &OHDUO\ GH¿QHG SULPDU\ DQG VHFRQGDU\ RXWFRPH PHDVXUH DQG ZKHQ applicable, any methods used to enhance the quality of measurements
(e.g., multiple observations, training of assessors)
How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules3DSHU VHFWLRQ DQG WRSLF ,WHP QXPEHU 'HVFULSWRU
5HSRUWHG RQ SDJH QXPEHU Title and abstract
1 How participants were allocated to intervention (e.g., “random allocation,” randomized, “ or randomly assigned”)
1 Introduction background
2
6FLHQWL¿F EDFNJURXQG DQG H[SODQDWLRQ RI UDWLRQDOH
2 Methods participants Interventions Objectives Outcomes Sample size
3
4
5
6
Precise details of the interventions intended for each group and how and what they were actually administered.
3
3
3
3
3
3 Randomization Sequence generation Allocation concealment Implementation Blinding (masking)
8
9
10
11
12 Method used to generate the random allocation sequence, including details RI DQ\ UHVWULFWLRQ H J EORFNLQJ VWUDWL¿FDWLRQ Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.
Whether or not participants, those administering the interventions, and those assessing the outcome were blinded to group assignment. If done, how the success of blinding was evaluated. Statistical methods used to compare groups for primary outcome (s); method additional analyses, such as subgroup analyses and adjusted analyses.
3
3
*HQHUDOL]DELOLW\ H[WHUQDO YDOLGLW\ RI WKH WULDO ¿QGLQJV
General interpretation of the results in the context of current evidence
Endoscopic Dilatation versus Oesophageal Stent in Benign Oesophageal Stricture
Self-expanding plastic or metal stents have been used to dilate benign recurrent oesophageal
VFRUH GXULQJ WKH ¿UVW PRQWKV ZKHUH G\VSKDJLD ZDV SDWLHQW DVVHVVHG RQ D ¿YH SRLQW VFDOH 6HFRQGDU\ endpoints assessed were: the number of repeat HQGRVFRSLF SURFHGXUHV WKHUDSHXWLF DQG GLDJQRVWLF DGYHUVH HYHQWV LQFOXGLQJ KRVSLWDO DGPLVVLRQV quality of life assessed physically using the surrogate PDUNHUV RI ZHLJKW JHQHULF TXDOLW\ RI OLIH DVVHVVPHQW
The primary outcome was the average dysphagia
5DQGRPLVDWLRQ ZDV ZHE EDVHG VWUDWLILHG E\ KRVSLWDO VLWH ZLWK D EORFN VL]H RI IRXU DOORFDWLQJ patients in a 1:1 ratio to biodegradable oesophageal stent (BS) or standard endoscopic balloon dilatation (' :KHQ WKH VWXG\ KDG UHFUXLWHG SDWLHQWV %6 DQG (' 2QH SDWLHQW IURP HDFK JURXS ZDV subsequently withdrawn before treatment due to in- HOLJLELOLW\ %6 PHQWDO LQFDSDFLW\ (' SULRU FDQFHU OHDYLQJ %6 DQG (' SDWLHQWV IRU DQDO\VLV
7KH ORQJHU SHUVLVWHQFH RI WKH 3'; VWHQW LV thought to allow adequate time for oesophageal remodelling to take place. Typically the stent PDLQWDLQV LQWHJULW\ DQG UDGLDO GLVWHQVLOH IRUFH IRU ZHHNV DQG GLVLQWHJUDWHV LQ ZHHNV IROORZLQJ implantation.
Biodegradable stents work to the same principle DV UHPRYDEOH PHWDO SODVWLF VWHQWV ZLWKRXW UHTXLULQJ endoscopic removal since the stent dissolves JUDGXDOO\ LQ VLWX WKXV DYRLGLQJ WKH QHHG IRU LW WR be removed. The biodegradable stent is made from SRO\GLR[DQRQH D PRQRFU\VWDOOLQH SRO\PHU WKDW KDV EHHQ XVHG LQ PRQR¿ODPHQW VXUJLFDO VXWXUH PDWHULDOV DQG KDV D FU\VWDOOLQH VWUXFWXUH ,W LV GHJUDGHG LQ living tissue by hydrolytic attack which breaks down the crystalline structure into smaller fragments.
VWHQW WKRUDFLF SDLQ DQG GLVDSSRLQWLQJ ORQJHU WHUP symptom relief.
VWHQWV RHVRSKDJHDO REVWUXFWLRQ GXH WR FROODSVHG
VWULFWXUHV DV D PHDQV RI UHGXFLQJ WKH QHHG IRU UHSHDWHG HQGRVFRSLF EDOORRQ ERXJLH dilatation with mixed UHVXOWV DQG SRWHQWLDO FRPSOLFDWLRQV RI VWHQW PLJUDWLRQ hyperplastic tissue ingrowth or overgrowth (metal
RHVRSKDJHDO FDQFHU DQG %DUUHWW¶V RHVRSKDJXV VXFK as endoscopic mucosal resection or photodynamic WKHUDS\ SRVW VXUJLFDO DQDVWRPRWLF VWULFWXUHV DQG eosinophilic oesophagitis.
reporting an RCT. Many leading medical journals and major international editorial groups have adopted the CONSORT statement.
VWULFWXUHV DUH LQMXU\ E\ DFLG UHÀX[ SHSWLF VWULFWXUHV UDGLDWLRQ LQGXFHG LQÀDPPDWRU\ VWULFWXUHV VHTXHODH of therapeutic endoscopic interventions for early
VWULFWXUHV GXH WR LQMXU\ E\ LQJHVWLRQ RI DFLG RU alkaline caustic agents (corrosive strictures). Other causes that cathegorized as benign oesophageal
Patient is cathegorized as benign oesophageal
VWULFWXUH DQG RSHQ XS WKH OXPHQ 0RVW SDWLHQWV respond to the dilatation well and maintain luminal patency of the oesophagus for a reasonable period of time.
7KLV VWDWHPHQW ¿WV WR WKH SDWLHQW ZKLFK KDG underwent a corrosive injury and had several times of dilation. Dilation stretches the narrowed oesophagus by radial distension. Stretching is EHOLHYHG WR GLVUXSW WKH FROODJHQ DQG HODVWLQ ¿EUHV LQ WKH RHVRSKDJHDO ZDOO UHVSRQVLEOH IRU WKH ¿EURWLF
The article state that balloon dilatation relieves G\VSKDJLD LQ DERXW RI SDWLHQWV DOWKRXJK associated with small risks of bleeding and SHUIRUDWLRQ DQG LQ DURXQG RI SDWLHQWV the stricture recurs needing repeated endoscopic dilatation. Recurrence appears more common for FRPSOH[ VWULFWXUHV UHODWHG WR UDGLDWLRQ WKHUDS\ corrosive injury or surgical anastomosis. Repeat dilatation is preferred for refractory strictures when FRPSDUHG WR VXUJHU\ ZKLFK LV DVVRFLDWHG ZLWK KLJK morbidity rates as well as high risk for patients with comorbidities.
The study has been using CONSORT guideline LQ UHSRUWLQJ WKH PHWKRGV IURP DEVWUDFW WR RXWFRPH $OVR LQ ÀRZ GLDJUDP LW KDV DOUHDG\ DGDSWHG 7KH study used a pilot multicentre randomised controlled trial design. Blinding of clinicians and patients ZDV QRW SUDFWLFDEOH HFRUGLQJ RI V\PSWRPV ZDV SHUIRUPHG E\ D VLQJOH EOLQGHG REVHUYHU DW EDVHOLQH DQG PRQWKV
',6&866,21
The objective of CONSORT is to facilitate critical appraisal and interpretation of RCTs by providing guidance to authors about how to improve the reporting of their trials. Peer reviewers and editors can also use CONSORT to help them identify reports that are GLI¿FXOW WR LQWHUSUHW DQG WKRVH ZLWK SRWHQWLDOO\ ELDVHG UHVXOWV +RZHYHU &216257 ZDV QRW PHDQW WR EH XVHG as a quality assessment instrument.
$OWKRXJK ERWK JURXSV LPSURYHG DYHUDJH dysphagia score for patients receiving stents UHPDLQHG VLJQL¿FDQWO\ KLJKHU DIWHU PRQWKV %6 (' &, S (VWLPDWLRQ RI dysphagia by AUC method was similar (noting the Hadyanto Caputra, Iqbal I Awang, Pringgodigdo Nugroho, Ari Fahrial Syam
ZHLJKWLQJ IRU D PRQWKV average. Stenting was DVVRFLDWHG ZLWK JUHDWHU G\VSKDJLD FR PHGLFDWLRQ and adverse events. This may have occurred in part because of chance atypical low dysphagia follow-up scores in the balloon dilatation group.
&21&/86,21
6WHQWLQJ ZDV DVVRFLDWHG ZLWK JUHDWHU G\VSKDJLD co-medication and adverse events. This may have occurred in part because of chance atypical low dysphagia follow-up scores in the balloon dilatation group. No randomized controlled trials comparing biodegradable stents with other stents or with EDOORRQ GLODWDWLRQ KDYH EHHQ LGHQWL¿HG /DFN RI adequately robust evidence for effectiveness and cost-effectiveness formed the rationale of this trial.
5()(5(1&(6 1.
&RQWLQL 6 6FDUSLJQDWR & &DXVWLF LQMXU\ RI WKH XSSHU gastrointestinal tract: a comprehensive review. World J
- DVWURHQWHURO .RED\DVKL 6 .DQDL 1 2KNL 7 7DNDJL 5 <DPDJXFKL 1 ,VRPRWR + HW DO 3UHYHQWLRQ RI HVRSKDJHDO VWULFWXUHV DIWHU endoscopic submucosal dissection. World J Gastroenterol %URRU 6/ .XPDU $ &KDUL 67 6LQJDO $ 0LVUD 63 .XPDU
1 HW DO &RUURVLYH RHVRSKDJHDO VWULFWXUHV IROORZLQJ DFLG LQJHVWLRQ FOLQLFDO SUR¿OH DQG UHVXOWV RI HQGRVFRSLFGLODWDWLRQ J Gastroenterol Hepatol 4. *XPDVWH 99 'DYH 3% ,QJHVWLRQ RI FRUURVLYH VXEVWDQFHV E\ DGXOWV $P - *DVWURHQWHURO
- DOOHU -$ $QGUHZV +* :KLWH -- 7DPHU 0$ &OHYHODQG WW. Pathophysiology and management of acute corrosive EXUQV RI WKH HVRSKDJXV UHVXOWV RI WUHDWPHQW LQ FKLOGUHQ
- 3HGLDWU 6XUJ 6. $FNUR\G 5 :DWVRQ ', 'HYLWW 3* -DPLHVRQ ** Expandable metallic stents should not be used in the treatment of benign esophageal strictures. J Gastroenterol +HSDWRO
6RQJ +< 3DUN 6, 'R <6 <RRQ +. 6XQJ .% 6RKQ .+ et al. Expandable metallic stent placement in patients with benign esophageal strictures: results of long-term follow- up. Radiology
6DLWR < 7DQDND 7 $QGRK $ 0LQHPDWVX + +DWD .
7VXMLNDZD 7 HW DO 8VHIXOQHVV RI ELRGHJUDGDEOH VWHQWV FRQVWUXFWHG RI SRO\ , ODFWLF DFLG PRQR¿ODPHQWV LQ SDWLHQWV with benign esophageal stenosis. World J Gastroenterol $OWPDQ '* 6FKXO] .) 0RKHU '. The riveised CONSORT Statement for Reporting Randomized Trial: Explanation DQG (ODERUDWLRQ $QQ ,QWHUQ 0HG
10.
'KDU $ &ORVH + 9LVZDQDWK <. 5HHV &- +DQFRFN +& 'ZDUDNDQDWK $' HW DO %LRGHJUDGDEOH VWHQW RU EDORRQ dilatation for beningn oesophageal stricture: Pilot randomised FRQWUROOHG WULDO :RUOG - *DVWURHQWHURO