- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02238938
Piecemeal Versus En Bloc Resection of Large Rectal Adenomas (PERLA)
Piecemeal Versus En Bloc Resection of Large Rectal Adenomas -A Prospective, Randomized Multicenter Study
Currently, colonoscopy is the safest way to detect bowel tumors and polyps, since these can be biopsied and removed in one working process. If the size of adenomas is larger than 2 cm, resections are usually done in a hospital setting. For the resection of large adenomas, different approaches can be used. The so-called piecemeal resection is done with snares, to cut off parts of the adenoma piece by piece until the whole adenoma is resected. This technique is the standard therapy, but is not required for very large adenomas, which can often show cell alterations that indicate cancer. Therefore these adenomas should be resected in one piece. This is done by the so-called en-bloc resection. For this kind of therapy, different endoscopic knifes are use to cut off the adenoma as a whole. Both resection techniques are done usually by previous injection of saline or other liquids to elevate the lesion from its bottom tissue.
Although the piecemeal resection of large adenoma is the standard therapy, it shows recurrence rates of 10 to 25%, which afford repeated therapies and follow up controls. En-bloc resections, though, are expected to have less recurrence rates but are much more complex to perform. They have higher complication rates especially in the West, where it has bee introduced only a couple of years ago.
The data situation regarding safety and efficacy of both therapies is low. This study is the first one ever to compare piecemeal EMR and ESD in a randomized way. The study might have influence on the logistics of future adenoma processing and patient flow.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In 20 to 35% of colonoscopies due to symptoms or for prevention polyps, so-called adenoma, are found. Currently, colonoscopy is the best way to detect bowel tumors and polyps, since these can be biopsied and removed in one working process. If the size of adenoma is larger than 2 cm, resections are usually done in a hospital setting. Foremost for flat adenoma, the resection by snares piece by piece, the so-called piecemeal polypectomy, or piecemeal endoscopic mucosal resection (EMR), is state of the art. Resection will usually follow a submucosal saline injection (saline assisted polypectomy). Recurrences occur in 10 up to 25 %, requiring a reapplication of endoscopic therapy and follow up examinations.
Depending on the size of adenoma, increasing amounts of cell alterations of an advanced stage such as high grade dysplasia / intraepithelial neoplasia (HGIN) up to early cancer are found. In these cases, for histo-pathological and oncological reasons, a resection in a solitary manner (en-bloc resection) is necessary to evaluate the completeness of resection properly. Also, former studies showed that recurrence rate could be decreased considerably by en-bloc resections, since the aim is to perform a complete resection basally and laterally. New endoscopic techniques of en-bloc resections have been introduced since a couple of years, using several endoscopic knifes to cut adenoma down after submucosal injection of liquid and consecutively dissect it from the tissue underneath. This technique is mostly called endoscopic submucosal dissection (ESD), and, with not too large adenoma, can be combined with snare resection, too. The complexity of this method though is much larger than that of snare resection. Therefore, the western success rate is considerably less than in Japan, where it was developed first, and where higher numbers of cases exist in the upper GI tract as well as in the lower GI tract. All in all, the complication rate of en-bloc resection is higher than that of snare resection. Those complications, mostly perforations, are endoscopically controllable in most cases, though.
In comparison with Japan, Korea or China, early malign lesions oft he upper GI tract in the West are rare. Therefore, this study will be conducted on (colo)rectal lesions, which appear much more often in the West.
All in all, for efficacy (resection in total, number of recurrences) and risk (perforations), there is an indistinct data situation between piecemeal resection (EMR) and en-bloc resection (ESD). Up to now, no randomised comparing data exist. The planned study is the first randomised study between ESD and piecemeal EMR at all, since there are no studies been done for the upper GI tract, either. For reasons of complexity, ESD will conceivably remain a method for specialized centers, while piecemeal polypectomies are done in numerous hospitals. Therefore, the outcomes of this study will have influence on future logistics in polypectomies and flow of patients with large colorectal adenoma.
Piecemeal resection will be done by snare following marking and submucosal injection of saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by snare or forceps. High resolution endoscopes are mandatory.
After three months, an Argon plasma coagulation (APC) therapy will follow any piecemeal resection, if necessary, another resection of leftover adenoma will be done. This second session can be done by sigmoidoscopy.
En- bloc resection is done after marking by use of different customary endoscopic knifes including combining devices as hybrid knife to cut down the lesion. After submucosal injection of liquid (saline or equivalent) to elevate the tissue it will be dissected and removed by a snare of adequate size solitarily. Since the aim of this method is the total resection basally and laterally, only one session is intended.
Follow-up care: sigmoidoscopy after 6 and 18 months, colonoscopy after 36 months each after the end of the primary therapy session(s). Diagnostics will be done endoscopically and histologically of at least 6 biopsies if the size of lesion was up to 3 cm, and of at least 10 biopsies for larger lesions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Berlin, Germany, 10365
- Sana Klinikum Lichtenberg
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Berlin, Germany, 12099
- Vivantes Wenckebach-Klinikum
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Hamburg, Germany, 20246
- University Hospital Eppendorf
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Hildesheim, Germany, 31134
- St. Bernward Krankenhaus
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Regensburg, Germany, 93049
- Krankenhaus Barmherzige Bruder Regensburg
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Portsmouth, United Kingdom, Havant PO9 5NP
- Portsmouth Hospitals NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients with large non pedunculated colorectal adenomas designated for endoscopic resection up to 15 cm ab ano, length 2 cm to 5 cm, maximum hemicircumferential
- age > 18 years
- signed Informed Consent
Exclusion Criteria:
- adenomas smaller or larger than described above
- more than one large rectal adenoma
- adenomas with known or suspected carcinoma, proven by previous biopsies
- adenomas with known or suspected carcinoma that do not seem to be resectable by endoscopy, e.g. ulcers, suspected infiltration of submucosa after endoscopic or ultrasound diagnostics
- patients with chronic inflammatory bowel diseases
- severe general disease, including metastasising carcinomas
- coagulation abnormalities or anticoagulant drug use which make resection therapy impossible
- bad general state of health (American Society of Anesthesiologists Classification (ASA) IV or more)
- pregnancy and lactation
- recurrence or leftover dysplasia after extended endoscopic or surgical therapy (transanal endoscopic microsurgery (TEM))
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: en-bloc resection
En- bloc resection is done after marking by use of different customary endoscopic knifes including combining devices as hybrid knife to cut down the lesion.
After submucosal injection of liquid (saline or equivalent) to elevate the tissue it will be dissected and removed by a snare of adequate size solitarily.
Since the aim of this method is the total resection basally and laterally, only one session is intended.
|
En- bloc resection after marking by use of different customary endoscopic knifes including combining devices as hybrid knife to cut down the lesion.
After submucosal injection of liquid (saline or equivalent) to elevate the tissue it will be dissected and removed by a snare of adequate size solitarily.
Other Names:
|
Active Comparator: piecemeal resection
Piecemeal resection will be done by snare following marking and submucosal injection of saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by snare or forceps. High resolution endoscopes are mandatory. After three months, an APC therapy will follow any piecemeal resection, if necessary, another resection of leftover adenoma will be done. This second session can be done by sigmoidoscopy. |
Piecemeal resection is done by snare after marking and submucosal injection of saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by snare or forceps. After three months, an APC therapy will follow any piecemeal resection, if necessary, another resection of leftover adenoma will be done.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
success rate of complete resection
Time Frame: 6 and 18 months after primary therapy
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success rate is confirmed by endoscopical diagnostics as well as histological diagnostics (at lest 6 biopsies in lesions up to 3 cm size, at least 10 biopsies in larger lesions).
Patients with no complete resection will be treated further according to clinical requirement, depending on histology.
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6 and 18 months after primary therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
en-bloc group: rate of R0 resections
Time Frame: timeline 0, day of en-bloc resection
|
This parameter is regarding histopathology.
Since piecemeal resections do not allow such a diagnosis, this parameter is only for the en-bloc resected group.
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timeline 0, day of en-bloc resection
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recurrence rate after complete adenoma resection
Time Frame: 36 months after initial resection
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Since early recurrences can evolve from leftover tumor cells and will become manifest after a time, the third control after two controls with negative biopsies.has
been chosen to be the gold standard.
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36 months after initial resection
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progress of therapy in patients with incomplete resection and recurrences
Time Frame: 36 months after initial resection
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patients will be treated further according to treatment standard depending on endoscopical and histological findings
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36 months after initial resection
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differences in the subgroups of adenomas
Time Frame: 5 years
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size, shape according to nice classification, low-grade and high grade intraepithelial adenomas, sm1 carcinomas
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5 years
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required time for the initial procedure
Time Frame: timeline 0, day of initial resection
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for piecemeal resections including second procedure with APC therapy
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timeline 0, day of initial resection
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complications including success of complication management
Time Frame: 5 years
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rate of complications that need intervention, e.g.
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5 years
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complications through patient sedation
Time Frame: timeline 0, day of initial resection
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depending on sedation standards of the participating centers
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timeline 0, day of initial resection
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resolution of tumor board for post resections and outcomes of patients with carcinoma histology
Time Frame: 5 years
|
patients with carcinoma histology will be discussed by a of tumor board
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5 years
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Collaborators and Investigators
Investigators
- Study Chair: Thomas Rösch, Prof. Dr., University Hospital Eppendorf, Hamburg
Publications and helpful links
General Publications
- Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25. Erratum In: Gastroenterology. 2021 Oct;161(4):1347.
- Adler A, Wegscheider K, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Gerber K, Stange G, Roll S, Gauger U, Wiedenmann B, Altenhofen L, Rosch T. Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3). Gut. 2013 Feb;62(2):236-41. doi: 10.1136/gutjnl-2011-300167. Epub 2012 Mar 22.
- Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.
- Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schroder A, Scheel M, Wiedenmann B, Rosch T. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial. Gastroenterology. 2009 Feb;136(2):410-6.e1; quiz 715. doi: 10.1053/j.gastro.2008.10.022. Epub 2008 Oct 15.
- Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rosch T. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut. 2008 Jan;57(1):59-64. doi: 10.1136/gut.2007.123539. Epub 2007 Aug 6.
- Adler A, Roll S, Marowski B, Drossel R, Rehs HU, Willich SN, Riese J, Wiedenmann B, Rosch T; Berlin Private-Practice Gastroenterology Working Group. Appropriateness of colonoscopy in the era of colorectal cancer screening: a prospective, multicenter study in a private-practice setting (Berlin Colonoscopy Project 1, BECOP 1). Dis Colon Rectum. 2007 Oct;50(10):1628-38. doi: 10.1007/s10350-007-9029-y.
- Lieberman DA, Weiss DG, Harford WV, Ahnen DJ, Provenzale D, Sontag SJ, Schnell TG, Chejfec G, Campbell DR, Kidao J, Bond JH, Nelson DB, Triadafilopoulos G, Ramirez FC, Collins JF, Johnston TK, McQuaid KR, Garewal H, Sampliner RE, Esquivel R, Robertson D. Five-year colon surveillance after screening colonoscopy. Gastroenterology. 2007 Oct;133(4):1077-85. doi: 10.1053/j.gastro.2007.07.006.
- Repici A, Hassan C, De Paula Pessoa D, Pagano N, Arezzo A, Zullo A, Lorenzetti R, Marmo R. Efficacy and safety of endoscopic submucosal dissection for colorectal neoplasia: a systematic review. Endoscopy. 2012 Feb;44(2):137-50. doi: 10.1055/s-0031-1291448. Epub 2012 Jan 23.
- Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. doi: 10.1053/j.gastro.2011.02.062. Epub 2011 Mar 8.
- Risio M. The natural history of colorectal adenomas and early cancer. Pathologe. 2012 Nov;33 Suppl 2:206-10. doi: 10.1007/s00292-012-1640-6.
- Saini SD, Kim HM, Schoenfeld P. Incidence of advanced adenomas at surveillance colonoscopy in patients with a personal history of colon adenomas: a meta-analysis and systematic review. Gastrointest Endosc. 2006 Oct;64(4):614-26. doi: 10.1016/j.gie.2006.06.057.
- Stegeman I, de Wijkerslooth TR, Stoop EM, van Leerdam ME, Dekker E, van Ballegooijen M, Kuipers EJ, Fockens P, Kraaijenhagen RA, Bossuyt PM. Colorectal cancer risk factors in the detection of advanced adenoma and colorectal cancer. Cancer Epidemiol. 2013 Jun;37(3):278-83. doi: 10.1016/j.canep.2013.02.004. Epub 2013 Mar 9.
- van Heijningen EM, Lansdorp-Vogelaar I, Kuipers EJ, Dekker E, Lesterhuis W, Ter Borg F, Vecht J, De Jonge V, Spoelstra P, Engels L, Bolwerk CJ, Timmer R, Kleibeuker JH, Koornstra JJ, van Ballegooijen M, Steyerberg EW. Features of adenoma and colonoscopy associated with recurrent colorectal neoplasia based on a large community-based study. Gastroenterology. 2013 Jun;144(7):1410-8. doi: 10.1053/j.gastro.2013.03.002. Epub 2013 Mar 7.
- Jang JH, Balik E, Kirchoff D, Tromp W, Kumar A, Grieco M, Feingold DL, Cekic V, Njoh L, Whelan RL. Oncologic colorectal resection, not advanced endoscopic polypectomy, is the best treatment for large dysplastic adenomas. J Gastrointest Surg. 2012 Jan;16(1):165-71; discussion 171-2. doi: 10.1007/s11605-011-1746-9. Epub 2011 Nov 5.
- Farhat S, Chaussade S, Ponchon T, Coumaros D, Charachon A, Barrioz T, Koch S, Houcke P, Cellier C, Heresbach D, Lepilliez V, Napoleon B, Bauret P, Coron E, Le Rhun M, Bichard P, Vaillant E, Calazel A, Bensoussan E, Bellon S, Mangialavori L, Robin F, Prat F; SFED ESD study group. Endoscopic submucosal dissection in a European setting. A multi-institutional report of a technique in development. Endoscopy. 2011 Aug;43(8):664-70. doi: 10.1055/s-0030-1256413. Epub 2011 May 27.
- Probst A, Pommer B, Golger D, Anthuber M, Arnholdt H, Messmann H. Endoscopic submucosal dissection in gastric neoplasia - experience from a European center. Endoscopy. 2010 Dec;42(12):1037-44. doi: 10.1055/s-0030-1255668. Epub 2010 Oct 22.
- Ribeiro-Mourao F, Pimentel-Nunes P, Dinis-Ribeiro M. Endoscopic submucosal dissection for gastric lesions: results of an European inquiry. Endoscopy. 2010 Oct;42(10):814-9. doi: 10.1055/s-0030-1255778. Epub 2010 Sep 30.
- Neuhaus H, Terheggen G, Rutz EM, Vieth M, Schumacher B. Endoscopic submucosal dissection plus radiofrequency ablation of neoplastic Barrett's esophagus. Endoscopy. 2012 Dec;44(12):1105-13. doi: 10.1055/s-0032-1310155. Epub 2012 Sep 11.
- Probst A, Golger D, Anthuber M, Markl B, Messmann H. Endoscopic submucosal dissection in large sessile lesions of the rectosigmoid: learning curve in a European center. Endoscopy. 2012 Jul;44(7):660-7. doi: 10.1055/s-0032-1309403. Epub 2012 Apr 23.
- Redaelli A, Cranor CW, Okano GJ, Reese PR. Screening, prevention and socioeconomic costs associated with the treatment of colorectal cancer. Pharmacoeconomics. 2003;21(17):1213-38. doi: 10.2165/00019053-200321170-00001.
- Soerjomataram I, Lortet-Tieulent J, Parkin DM, Ferlay J, Mathers C, Forman D, Bray F. Global burden of cancer in 2008: a systematic analysis of disability-adjusted life-years in 12 world regions. Lancet. 2012 Nov 24;380(9856):1840-50. doi: 10.1016/S0140-6736(12)60919-2. Epub 2012 Oct 16.
- van den Broek FJ, de Graaf EJ, Dijkgraaf MG, Reitsma JB, Haringsma J, Timmer R, Weusten BL, Gerhards MF, Consten EC, Schwartz MP, Boom MJ, Derksen EJ, Bijnen AB, Davids PH, Hoff C, van Dullemen HM, Heine GD, van der Linde K, Jansen JM, Mallant-Hent RC, Breumelhof R, Geldof H, Hardwick JC, Doornebosch PG, Depla AC, Ernst MF, van Munster IP, de Hingh IH, Schoon EJ, Bemelman WA, Fockens P, Dekker E. Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study). BMC Surg. 2009 Mar 13;9:4. doi: 10.1186/1471-2482-9-4.
- Kim HH, Kim JH, Park SJ, Park MI, Moon W. Risk factors for incomplete resection and complications in endoscopic mucosal resection for lateral spreading tumors. Dig Endosc. 2012 Jul;24(4):259-66. doi: 10.1111/j.1443-1661.2011.01232.x. Epub 2012 Feb 7.
- Kobayashi N, Yoshitake N, Hirahara Y, Konishi J, Saito Y, Matsuda T, Ishikawa T, Sekiguchi R, Fujimori T. Matched case-control study comparing endoscopic submucosal dissection and endoscopic mucosal resection for colorectal tumors. J Gastroenterol Hepatol. 2012 Apr;27(4):728-33. doi: 10.1111/j.1440-1746.2011.06942.x.
- Ahlawat SK, Gupta N, Benjamin SB, Al-Kawas FH. Large colorectal polyps: endoscopic management and rate of malignancy: does size matter? J Clin Gastroenterol. 2011 Apr;45(4):347-54. doi: 10.1097/MCG.0b013e3181f3a2e0.
- Ah Soune P, Menard C, Salah E, Desjeux A, Grimaud JC, Barthet M. Large endoscopic mucosal resection for colorectal tumors exceeding 4 cm. World J Gastroenterol. 2010 Feb 7;16(5):588-95. doi: 10.3748/wjg.v16.i5.588.
- Hurlstone DP, Sanders DS, Cross SS, George R, Shorthouse AJ, Brown S. A prospective analysis of extended endoscopic mucosal resection for large rectal villous adenomas: an alternative technique to transanal endoscopic microsurgery. Colorectal Dis. 2005 Jul;7(4):339-44. doi: 10.1111/j.1463-1318.2005.00813.x.
- Pigot F, Bouchard D, Mortaji M, Castinel A, Juguet F, Chaume JC, Faivre J. Local excision of large rectal villous adenomas: long-term results. Dis Colon Rectum. 2003 Oct;46(10):1345-50. doi: 10.1007/s10350-004-6748-1.
- Doniec JM, Lohnert MS, Schniewind B, Bokelmann F, Kremer B, Grimm H. Endoscopic removal of large colorectal polyps: prevention of unnecessary surgery? Dis Colon Rectum. 2003 Mar;46(3):340-8. doi: 10.1007/s10350-004-6553-x.
- Rosch T, Sarbia M, Schumacher B, Deinert K, Frimberger E, Toermer T, Stolte M, Neuhaus H. Attempted endoscopic en bloc resection of mucosal and submucosal tumors using insulated-tip knives: a pilot series. Endoscopy. 2004 Sep;36(9):788-801. doi: 10.1055/s-2004-825838.
- Neuhaus H, Costamagna G, Deviere J, Fockens P, Ponchon T, Rosch T; ARCADE Group. Endoscopic submucosal dissection (ESD) of early neoplastic gastric lesions using a new double-channel endoscope (the "R-scope"). Endoscopy. 2006 Oct;38(10):1016-23. doi: 10.1055/s-2006-944830.
- Pohl H, Aschenbeck J, Drossel R, Schroder A, Mayr M, Koch M, Rothe K, Anders M, Voderholzer W, Hoffmann J, Schulz HJ, Liehr RM, Gottschalk U, Wiedenmann B, Rosch T. Endoscopy in Barrett's oesophagus: adherence to standards and neoplasia detection in the community practice versus hospital setting. J Intern Med. 2008 Oct;264(4):370-8. doi: 10.1111/j.1365-2796.2008.01977.x. Epub 2008 May 15.
- Meining A, Ott R, Becker I, Hahn S, Muhlen J, Werner M, Hofler H, Classen M, Heldwein W, Rosch T. The Munich Barrett follow up study: suspicion of Barrett's oesophagus based on either endoscopy or histology only--what is the clinical significance? Gut. 2004 Oct;53(10):1402-7. doi: 10.1136/gut.2003.036822.
- Heldwein W, Dollhopf M, Rosch T, Meining A, Schmidtsdorff G, Hasford J, Hermanek P, Burlefinger R, Birkner B, Schmitt W; Munich Gastroenterology Group. The Munich Polypectomy Study (MUPS): prospective analysis of complications and risk factors in 4000 colonic snare polypectomies. Endoscopy. 2005 Nov;37(11):1116-22. doi: 10.1055/s-2005-870512.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PERLA
- PV 4580 (Registry Identifier: Ethics committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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