Colorectal Adenoma With Mild DysplasiaPERLANCT02238938
Piecemeal Versus En Bloc Resection of Large Rectal Adenomas
A study testing en-bloc resection and piecemeal resection in people with Colorectal Adenoma With Mild Dysplasia and Colorectal Adenoma With Severe Dysplasia, run by Universitätsklinikum Hamburg-Eppendorf at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenoma With Mild Dysplasia, Colorectal Adenoma With Severe Dysplasia, Colorectal Adenomatous Polyp
- What is being tested?
- en-bloc resection and piecemeal resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Apr 2014to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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))
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany5 sites
Sana Klinikum Lichtenberg
Berlin, 10365
Vivantes Wenckebach-Klinikum
Berlin, 12099
University Hospital Eppendorf
Hamburg, 20246
St. Bernward Krankenhaus
Hildesheim, 31134
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, 93049
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, Havant PO9 5NP
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Adenoma With Mild Dysplasia, Colorectal Adenoma With Severe Dysplasia, Colorectal Adenomatous Polyp, Colorectal Low Grade Intraepithelial Neoplasia, Colorectal High Grade Intraepithelial Neoplasia
- Being tested
- en-bloc resection, piecemeal resection
- Keywords
- piecemeal polypectomy, piecemeal endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), endoscopic en-bloc resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
en-bloc resectionProcedure or surgery
Also called endoscopic submucosal dissection, ESD
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.
piecemeal resectionProcedure or surgery
Also called piecemeal polypectomy, piecemeal endoscopic mucosal resection, piecemeal EMR
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.
| Study group | Role | What they receive |
|---|---|---|
| en-bloc resection | Experimental | 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. Receives: Procedure: en-bloc resection |
| piecemeal resection | Active comparator | 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. Receives: Procedure: piecemeal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of complete resection
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.
Measured: 6 and 18 months after primary therapy
Secondary outcomes (8)
en-bloc group: rate of R0 resections
This parameter is regarding histopathology. Since piecemeal resections do not allow such a diagnosis, this parameter is only for the en-bloc resected group.
Measured: timeline 0, day of en-bloc resection
recurrence rate after complete adenoma resection
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.
Measured: 36 months after initial resection
progress of therapy in patients with incomplete resection and recurrences
patients will be treated further according to treatment standard depending on endoscopical and histological findings
Measured: 36 months after initial resection
differences in the subgroups of adenomas
size, shape according to nice classification, low-grade and high grade intraepithelial adenomas, sm1 carcinomas
Measured: 5 years
required time for the initial procedure
for piecemeal resections including second procedure with APC therapy
Measured: timeline 0, day of initial resection
complications including success of complication management
rate of complications that need intervention, e.g.
- perforation (intra - and post procedural, surgery, additional procedures such as antibiotics, monitoring, intensive care
- secondary haemorrhage (second look endoscopy, surgery)
- infection
Measured: 5 years
complications through patient sedation
depending on sedation standards of the participating centers
Measured: timeline 0, day of initial resection
resolution of tumor board for post resections and outcomes of patients with carcinoma histology
patients with carcinoma histology will be discussed by a of tumor board
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startApr 2014
- Primary completion30 May 2021
- Study completion30 May 2022
Why it stopped: insufficient recruitment of study patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Colorectal Adenoma With Mild DysplasiaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Thomas Rösch, Prof. Dr., Study chair, University Hospital Eppendorf, Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238938
- Sponsor's protocol ID
- PERLA
- Other IDs
- PV 4580
- Acronym
- PERLA
- Status last verified
- Jun 2023
- First submitted
- 4 Sep 2014
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22945585Lieberman 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.
PubMed 17698067Saini 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.
PubMed 16996358Stegeman 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.
PubMed 23491770van 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.
PubMed 23499951Jang 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.
PubMed 22058042Repici 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.
PubMed 22271024Farhat 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.
PubMed 21623560Probst 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.
PubMed 20972955Ribeiro-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.
PubMed 20886399Neuhaus 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.
PubMed 22968641Probst 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.
PubMed 22528673Adler 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.
PubMed 17694415Redaelli 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.
PubMed 14986736Soerjomataram 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.
PubMed 23079588
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piecemeal Versus En Bloc Resection of Large Rectal Adenomas -A Prospective, Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT02238938
- Acronym / sponsor ID
- PERLA / PERLA
- Conditions
- Colorectal Adenoma With Mild Dysplasia, Colorectal Adenoma With Severe Dysplasia, Colorectal Adenomatous Polyp, Colorectal Low Grade Intraepithelial Neoplasia, Colorectal High Grade Intraepithelial Neoplasia
- Keywords
- piecemeal polypectomy, piecemeal endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), endoscopic en-bloc resection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment of study patients
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| en-bloc resection | Experimental | Procedure: en-bloc resectionEn- 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. |
| piecemeal resection | Active comparator | Procedure: piecemeal resectionPiecemeal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| en-bloc resectionAlso: endoscopic submucosal dissection, ESDEn- 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. | Procedure or surgery | en-bloc resection |
| piecemeal resectionAlso: piecemeal polypectomy, piecemeal endoscopic mucosal resection, piecemeal EMRPiecemeal 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. | Procedure or surgery | piecemeal resection |
Primary outcome
success rate of complete resection
Time frame: 6 and 18 months after primary therapy
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.
8 secondary outcomes
en-bloc group: rate of R0 resections
Time frame: timeline 0, day of en-bloc resection
recurrence rate after complete adenoma resection
Time frame: 36 months after initial resection
progress of therapy in patients with incomplete resection and recurrences
Time frame: 36 months after initial resection
differences in the subgroups of adenomas
Time frame: 5 years
required time for the initial procedure
Time frame: timeline 0, day of initial resection
complications including success of complication management
Time frame: 5 years
complications through patient sedation
Time frame: timeline 0, day of initial resection
resolution of tumor board for post resections and outcomes of patients with carcinoma histology
Time frame: 5 years
Results and safety
The study was stopped early (reason given: insufficient recruitment of study patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Background: PubMed 22945585Risio 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Rösch, Prof. Dr. study chair
University Hospital Eppendorf, Hamburg
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing en-bloc resection and piecemeal resection in people with Colorectal Adenoma With Mild Dysplasia and Colorectal Adenoma With Severe Dysplasia, run by Universitätsklinikum Hamburg-Eppendorf at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment of study patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of complete resection (time frame: 6 and 18 months after primary therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02238938, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.