Rectal Neuroendocrine TumorTRACE-NETNCT07848360
Traction-Assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors
A study testing Traction-Assisted Endoscopic Submucosal Dissection and Conventional Endoscopic Submucosal Dissection in people with Rectal Neuroendocrine Tumor, run by Pusan National University Hospital.
Trial summary
This prospective, randomized pilot study will compare traction-assisted endoscopic submucosal dissection (T-ESD) with conventional endoscopic submucosal dissection (C-ESD) for the treatment of rectal neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rectal Neuroendocrine Tumor
- What is being tested?
- Traction-Assisted Endoscopic Submucosal Dissection and Conventional Endoscopic Submucosal Dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older.
- Patients diagnosed with or strongly suspected of having a rectal neuroendocrine tumor on colonoscopy.
- Lesion size generally 15 mm or less, without suspected muscularis propria invasion on endoscopy and, when clinically indicated, endoscopic ultrasonography.
- No suspected lymph node metastasis or distant metastasis based on abdominal/pelvic imaging or clinical assessment.
- Lesions considered appropriate for endoscopic resection.
- Ability to understand the purpose and procedures of the study and provide written informed consent.
Who cannot join
- Suspected muscularis propria invasion, lymph node metastasis, or distant metastasis on endoscopy, endoscopic ultrasonography, imaging studies, or clinical assessment.
- Lesion size greater than 15 mm, or a lesion considered by the investigator to require surgical treatment rather than endoscopic resection.
- Conditions that make safe endoscopic submucosal dissection difficult, including inadequate bowel preparation.
- Uncontrolled bleeding tendency, severe thrombocytopenia, or uncorrectable coagulation disorder.
- Use of antiplatelet or anticoagulant therapy that cannot be appropriately discontinued or adjusted before the procedure.
- Severe cardiopulmonary disease, hepatic failure, renal failure, or other conditions considered to make sedation or endoscopic submucosal dissection unsafe.
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- Pregnancy or breastfeeding.
- Inability to provide informed consent or impaired decision-making capacity.
- Altered anatomy of the rectum due to previous rectal surgery, radiotherapy, or other conditions that may interfere with standardization of the study procedure.
- Any other condition considered by the principal investigator or study investigator to make participation inappropriate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Traction-assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors: A Prospective Randomized Study
This prospective, randomized pilot study will compare traction-assisted endoscopic submucosal dissection (T-ESD) with conventional endoscopic submucosal dissection (C-ESD) for the treatment of rectal neuroendocrine tumors. Patients with rectal neuroendocrine tumors generally measuring 15 mm or less, without suspected muscularis propria invasion, lymph node metastasis, or distant metastasis, who are considered suitable for endoscopic resection will be eligible for enrollment.
Participants will be randomly assigned in a 1:1 ratio to undergo either T-ESD or C-ESD. In the T-ESD group, a traction device will be used during submucosal dissection to improve visualization of the submucosal layer, whereas conventional ESD will be performed without routine use of a traction device.
The primary outcome is resection speed, calculated as the resected specimen area divided by the submucosal dissection time. Secondary outcomes include total procedure time, submucosal dissection time, en bloc and R0 resection rates, resection margin status, procedure-related adverse events, length of hospital stay, time to diet resumption, and unplanned emergency department visits or readmissions. The study is designed as an exploratory pilot trial to estimate the efficacy, safety, and variability of traction-assisted ESD and to provide preliminary data for the design of a future larger multicenter randomized trial.
- Conditions
- Rectal Neuroendocrine Tumor
- Being tested
- Traction-Assisted Endoscopic Submucosal Dissection, Conventional Endoscopic Submucosal Dissection
- Keywords
- Rectal neuroendocrine tumor, Endoscopic submucosal dissection, Traction-assisted endoscopic submucosal dissection, Conventional endoscopic submucosal dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traction-Assisted Endoscopic Submucosal DissectionProcedure or surgery
Also called T-ESD, TA-ESD
After submucosal injection and mucosal incision, a standardized traction device will be applied to the lesion to provide traction and improve visualization of the submucosal layer.
Conventional Endoscopic Submucosal DissectionProcedure or surgery
Also called C-ESD
After submucosal injection, mucosal incision and submucosal dissection will be performed using conventional endoscopic submucosal dissection techniques without use of a traction device
| Study group | Role | What they receive |
|---|---|---|
| Traction-Assisted Endoscopic Submucosal Dissection | Experimental | Participants assigned to this arm will undergo traction-assisted endoscopic submucosal dissection (T-ESD). Receives: Procedure: Traction-Assisted Endoscopic Submucosal Dissection |
| Conventional Endoscopic Submucosal Dissection | Active comparator | Participants assigned to this arm will undergo conventional endoscopic submucosal dissection (C-ESD). Receives: Procedure: Conventional Endoscopic Submucosal Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection speed
Resection speed will be calculated as the resected specimen area (mm²) divided by the submucosal dissection time (min). The resected specimen area will be calculated using the ellipse formula: π × (major axis/2) × (minor axis/2). Submucosal dissection time will be measured from the start of submucosal dissection to complete resection of the lesion. The outcome will be expressed as mm²/min.
Measured: During the ESD procedure, from the start of submucosal dissection to complete lesion resection
Secondary outcomes (13)
Total Procedure Time
Total procedure time will be measured from the start of the initial lesion marking to complete resection of the lesion and will be expressed in minutes.
Measured: At completion of the ESD procedure
Submucosal Dissection Time
Submucosal dissection time will be measured from the start of submucosal dissection to complete resection of the lesion and will be expressed in minutes.
Measured: During the ESD procedure
Traction Application Time
Time during which the traction device is applied during the ESD procedure in participants assigned to the traction-assisted ESD group, expressed in minutes.
Measured: During the ESD procedure
En Bloc Resection Rate
The proportion of participants in whom the target lesion is resected in a single piece.
Measured: At completion of the ESD procedure
R0 Resection Rate
The proportion of participants with histologically complete resection, defined as both negative horizontal and negative vertical resection margins.
Measured: Postprocedurally, generally within 1 month after ESD
Horizontal Resection Margin Status
The proportion of participants with a histologically negative horizontal resection margin.
Measured: Postprocedurally, generally within 1 month after ESD
Vertical Resection Margin Status
The proportion of participants with a histologically negative vertical resection margin.
Measured: Postprocedurally, generally within 1 month after ESD
Horizontal Resection Margin Distance
The shortest histopathologic distance from the lateral tumor edge to the horizontal resection margin will be measured in millimeters on the resected specimen.
Measured: Postprocedurally, generally within 1 month after ESD
Vertical Resection Margin Distance
The shortest histopathologic distance from the deepest tumor edge to the vertical resection margin will be measured in millimeters on the resected specimen.
Measured: Postprocedurally, generally within 1 month after ESD
Procedure-Related Adverse Events
The incidence of procedure-related adverse events, including intraprocedural bleeding, delayed bleeding, intraprocedural perforation, delayed perforation, muscularis propria injury, post-ESD coagulation syndrome, and the need for additional endoscopic or surgical treatment.
Measured: From the start of ESD through 1 month after the procedure
Length of Hospital Stay
Length of hospital stay after the ESD procedure, measured in days.
Measured: Periprocedural
Time to Diet Resumption
Time from completion of the ESD procedure to resumption of oral diet.
Measured: Periprocedural
Unplanned Emergency Department Visit or Readmission
The proportion of participants who experience an unplanned emergency department visit or hospital readmission after the ESD procedure.
Measured: From the start of ESD through 1 month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rectal Neuroendocrine TumorStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Min Hong, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848360
- Sponsor's protocol ID
- 2607-035-165
- Other IDs
- 2607-035-165
- Acronym
- TRACE-NET
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the primary publication may be shared upon reasonable request. Shared data may include participant characteristics, lesion characteristics, procedural variables, histopathologic outcomes, safety outcomes, and clinical course variables collected in this study.
Publications
Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.
PubMed 28212588Tanaka S, Kashida H, Saito Y, Yahagi N, Yamano H, Saito S, Hisabe T, Yao T, Watanabe M, Yoshida M, Saitoh Y, Tsuruta O, Sugihara KI, Igarashi M, Toyonaga T, Ajioka Y, Kusunoki M, Koike K, Fujimoto K, Tajiri H. Japan Gastroenterological Endoscopy Society guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Dig Endosc. 2020 Jan;32(2):219-239. doi: 10.1111/den.13545. Epub 2019 Dec 27.
PubMed 31566804Ramage JK, De Herder WW, Delle Fave G, Ferolla P, Ferone D, Ito T, Ruszniewski P, Sundin A, Weber W, Zheng-Pei Z, Taal B, Pascher A; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Colorectal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):139-43. doi: 10.1159/000443166. Epub 2016 Jan 5. No abstract available.
PubMed 26730835Pimentel-Nunes P, Libanio D, Bastiaansen BAJ, Bhandari P, Bisschops R, Bourke MJ, Esposito G, Lemmers A, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, van Hooft JE, Deprez PH, Dinis-Ribeiro M. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2022 Jun;54(6):591-622. doi: 10.1055/a-1811-7025. Epub 2022 May 6.
PubMed 35523224Rinke A, Ambrosini V, Dromain C, Garcia-Carbonero R, Haji A, Koumarianou A, van Dijkum EN, O'Toole D, Rindi G, Scoazec JY, Ramage J. European Neuroendocrine Tumor Society (ENETS) 2023 guidance paper for colorectal neuroendocrine tumours. J Neuroendocrinol. 2023 Jun;35(6):e13309. doi: 10.1111/jne.13309. Epub 2023 Jun 22.
PubMed 37345509Wu S, Zhou Y, Ji D, Cai X, Shen L, Yu X, Xia J, Zhu M, Zhao X, Shi Y, Ning M, Wan XJ, Dong ZX. Traction-assisted endoscopic submucosal resection (TA-ESD) for rectal neuroendocrine tumors: a randomized multi-center trial. Surg Endosc. 2025 Aug;39(8):5430-5438. doi: 10.1007/s00464-025-11934-8. Epub 2025 Jul 9.
PubMed 40634728Peng J, Lin J, Fang L, Zhou J, Song Y, Yang C, Zhang Y, Gu B, Ji Z, Lu Y, Mao X, Yan L. Conventional versus rubber band traction-assisted endoscopic submucosal dissection for rectal neuroendocrine tumors: a single-center retrospective study (with video). Surg Endosc. 2024 Nov;38(11):6485-6492. doi: 10.1007/s00464-024-11244-5. Epub 2024 Sep 13.
PubMed 39271513Ichijima R, Ikehara H, Sumida Y, Inada T, Nemoto D, Nakajima Y, Minagawa T, Sumiyoshi T, Inoki K, Yoshida N, Inoue K, Fukuzawa M, Minoda Y, Tsutsumi K, Esaki M, Gotoda T. Randomized controlled trial comparing conventional and traction endoscopic submucosal dissection for early colon tumor (CONNECT-C trial). Dig Endosc. 2023 Jan;35(1):86-93. doi: 10.1111/den.14426. Epub 2022 Oct 3.
PubMed 35997037Tamaru Y, Kuwai T, Miyakawa A, Kanazawa N, Kusunoki R, Shimura H, Uchiyama S, Ishaq S, Kohno H. Efficacy of a Traction Device for Endoscopic Submucosal Dissection Using a Scissor-Type Knife: A Randomized Controlled Trial. Am J Gastroenterol. 2022 Nov 1;117(11):1797-1804. doi: 10.14309/ajg.0000000000002019. Epub 2022 Sep 26.
PubMed 36191269Yamasaki Y, Takeuchi Y, Uedo N, Kato M, Hamada K, Aoi K, Tonai Y, Matsuura N, Kanesaka T, Yamashina T, Akasaka T, Hanaoka N, Higashino K, Ishihara R, Iishi H. Traction-assisted colonic endoscopic submucosal dissection using clip and line: a feasibility study. Endosc Int Open. 2016 Jan;4(1):E51-5. doi: 10.1055/s-0041-107779. Epub 2015 Nov 30.
PubMed 26793785Fuccio L, Hassan C, Ponchon T, Mandolesi D, Farioli A, Cucchetti A, Frazzoni L, Bhandari P, Bellisario C, Bazzoli F, Repici A. Clinical outcomes after endoscopic submucosal dissection for colorectal neoplasia: a systematic review and meta-analysis. Gastrointest Endosc. 2017 Jul;86(1):74-86.e17. doi: 10.1016/j.gie.2017.02.024. Epub 2017 Feb 28.
PubMed 28254526Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.
PubMed 24671869
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traction-assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07848360
- Acronym / sponsor ID
- TRACE-NET / 2607-035-165
- Conditions
- Rectal Neuroendocrine Tumor
- Keywords
- Rectal neuroendocrine tumor, Endoscopic submucosal dissection, Traction-assisted endoscopic submucosal dissection, Conventional endoscopic submucosal dissection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- 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.
This prospective, randomized pilot study will compare traction-assisted endoscopic submucosal dissection (T-ESD) with conventional endoscopic submucosal dissection (C-ESD) for the treatment of rectal neuroendocrine tumors. Patients with rectal neuroendocrine tumors generally measuring 15 mm or less, without suspected muscularis propria invasion, lymph node metastasis, or distant metastasis, who are considered suitable for endoscopic resection will be eligible for enrollment.
Participants will be randomly assigned in a 1:1 ratio to undergo either T-ESD or C-ESD. In the T-ESD group, a traction device will be used during submucosal dissection to improve visualization of the submucosal layer, whereas conventional ESD will be performed without routine use of a traction device.
The primary outcome is resection speed, calculated as the resected specimen area divided by the submucosal dissection time. Secondary outcomes include total procedure time, submucosal dissection time, en bloc and R0 resection rates, resection margin status, procedure-related adverse events, length of hospital stay, time to diet resumption, and unplanned emergency department visits or readmissions. The study is designed as an exploratory pilot trial to estimate the efficacy, safety, and variability of traction-assisted ESD and to provide preliminary data for the design of a future larger multicenter randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traction-Assisted Endoscopic Submucosal Dissection | Experimental | Procedure: Traction-Assisted Endoscopic Submucosal DissectionParticipants assigned to this arm will undergo traction-assisted endoscopic submucosal dissection (T-ESD). |
| Conventional Endoscopic Submucosal Dissection | Active comparator | Procedure: Conventional Endoscopic Submucosal DissectionParticipants assigned to this arm will undergo conventional endoscopic submucosal dissection (C-ESD). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 19 years or older.
- Patients diagnosed with or strongly suspected of having a rectal neuroendocrine tumor on colonoscopy.
- Lesion size generally 15 mm or less, without suspected muscularis propria invasion on endoscopy and, when clinically indicated, endoscopic ultrasonography.
- No suspected lymph node metastasis or distant metastasis based on abdominal/pelvic imaging or clinical assessment.
- Lesions considered appropriate for endoscopic resection.
Key exclusion criteria (10 listed)
- Suspected muscularis propria invasion, lymph node metastasis, or distant metastasis on endoscopy, endoscopic ultrasonography, imaging studies, or clinical assessment.
- Lesion size greater than 15 mm, or a lesion considered by the investigator to require surgical treatment rather than endoscopic resection.
- Conditions that make safe endoscopic submucosal dissection difficult, including inadequate bowel preparation.
- Uncontrolled bleeding tendency, severe thrombocytopenia, or uncorrectable coagulation disorder.
- Use of antiplatelet or anticoagulant therapy that cannot be appropriately discontinued or adjusted before the procedure.
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 |
|---|---|---|
| Traction-Assisted Endoscopic Submucosal DissectionAlso: T-ESD, TA-ESDAfter submucosal injection and mucosal incision, a standardized traction device will be applied to the lesion to provide traction and improve visualization of the submucosal layer. | Procedure or surgery | Traction-Assisted Endoscopic Submucosal Dissection |
| Conventional Endoscopic Submucosal DissectionAlso: C-ESDAfter submucosal injection, mucosal incision and submucosal dissection will be performed using conventional endoscopic submucosal dissection techniques without use of a traction device | Procedure or surgery | Conventional Endoscopic Submucosal Dissection |
Primary outcome
Resection speed
Time frame: During the ESD procedure, from the start of submucosal dissection to complete lesion resection
Resection speed will be calculated as the resected specimen area (mm²) divided by the submucosal dissection time (min). The resected specimen area will be calculated using the ellipse formula: π × (major axis/2) × (minor axis/2). Submucosal dissection time will be measured from the start of submucosal dissection to complete resection of the lesion. The outcome will be expressed as mm²/min.
13 secondary outcomes
Total Procedure Time
Time frame: At completion of the ESD procedure
Submucosal Dissection Time
Time frame: During the ESD procedure
Traction Application Time
Time frame: During the ESD procedure
En Bloc Resection Rate
Time frame: At completion of the ESD procedure
R0 Resection Rate
Time frame: Postprocedurally, generally within 1 month after ESD
Horizontal Resection Margin Status
Time frame: Postprocedurally, generally within 1 month after ESD
Vertical Resection Margin Status
Time frame: Postprocedurally, generally within 1 month after ESD
Horizontal Resection Margin Distance
Time frame: Postprocedurally, generally within 1 month after ESD
Vertical Resection Margin Distance
Time frame: Postprocedurally, generally within 1 month after ESD
Procedure-Related Adverse Events
Time frame: From the start of ESD through 1 month after the procedure
Length of Hospital Stay
Time frame: Periprocedural
Time to Diet Resumption
Time frame: Periprocedural
Unplanned Emergency Department Visit or Readmission
Time frame: From the start of ESD through 1 month after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 28212588Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.
- Background: PubMed 31566804Tanaka S, Kashida H, Saito Y, Yahagi N, Yamano H, Saito S, Hisabe T, Yao T, Watanabe M, Yoshida M, Saitoh Y, Tsuruta O, Sugihara KI, Igarashi M, Toyonaga T, Ajioka Y, Kusunoki M, Koike K, Fujimoto K, Tajiri H. Japan Gastroenterological Endoscopy Society guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Dig Endosc. 2020 Jan;32(2):219-239. doi: 10.1111/den.13545. Epub 2019 Dec 27.
- Background: PubMed 26730835Ramage JK, De Herder WW, Delle Fave G, Ferolla P, Ferone D, Ito T, Ruszniewski P, Sundin A, Weber W, Zheng-Pei Z, Taal B, Pascher A; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Colorectal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):139-43. doi: 10.1159/000443166. Epub 2016 Jan 5. No abstract available.
- Background: PubMed 35523224Pimentel-Nunes P, Libanio D, Bastiaansen BAJ, Bhandari P, Bisschops R, Bourke MJ, Esposito G, Lemmers A, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, van Hooft JE, Deprez PH, Dinis-Ribeiro M. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2022 Jun;54(6):591-622. doi: 10.1055/a-1811-7025. Epub 2022 May 6.
- Background: PubMed 37345509Rinke A, Ambrosini V, Dromain C, Garcia-Carbonero R, Haji A, Koumarianou A, van Dijkum EN, O'Toole D, Rindi G, Scoazec JY, Ramage J. European Neuroendocrine Tumor Society (ENETS) 2023 guidance paper for colorectal neuroendocrine tumours. J Neuroendocrinol. 2023 Jun;35(6):e13309. doi: 10.1111/jne.13309. Epub 2023 Jun 22.
- Background: PubMed 40634728Wu S, Zhou Y, Ji D, Cai X, Shen L, Yu X, Xia J, Zhu M, Zhao X, Shi Y, Ning M, Wan XJ, Dong ZX. Traction-assisted endoscopic submucosal resection (TA-ESD) for rectal neuroendocrine tumors: a randomized multi-center trial. Surg Endosc. 2025 Aug;39(8):5430-5438. doi: 10.1007/s00464-025-11934-8. Epub 2025 Jul 9.
- Background: PubMed 39271513Peng J, Lin J, Fang L, Zhou J, Song Y, Yang C, Zhang Y, Gu B, Ji Z, Lu Y, Mao X, Yan L. Conventional versus rubber band traction-assisted endoscopic submucosal dissection for rectal neuroendocrine tumors: a single-center retrospective study (with video). Surg Endosc. 2024 Nov;38(11):6485-6492. doi: 10.1007/s00464-024-11244-5. Epub 2024 Sep 13.
- Background: PubMed 35997037Ichijima R, Ikehara H, Sumida Y, Inada T, Nemoto D, Nakajima Y, Minagawa T, Sumiyoshi T, Inoki K, Yoshida N, Inoue K, Fukuzawa M, Minoda Y, Tsutsumi K, Esaki M, Gotoda T. Randomized controlled trial comparing conventional and traction endoscopic submucosal dissection for early colon tumor (CONNECT-C trial). Dig Endosc. 2023 Jan;35(1):86-93. doi: 10.1111/den.14426. Epub 2022 Oct 3.
- Background: PubMed 36191269Tamaru Y, Kuwai T, Miyakawa A, Kanazawa N, Kusunoki R, Shimura H, Uchiyama S, Ishaq S, Kohno H. Efficacy of a Traction Device for Endoscopic Submucosal Dissection Using a Scissor-Type Knife: A Randomized Controlled Trial. Am J Gastroenterol. 2022 Nov 1;117(11):1797-1804. doi: 10.14309/ajg.0000000000002019. Epub 2022 Sep 26.
- Background: PubMed 26793785Yamasaki Y, Takeuchi Y, Uedo N, Kato M, Hamada K, Aoi K, Tonai Y, Matsuura N, Kanesaka T, Yamashina T, Akasaka T, Hanaoka N, Higashino K, Ishihara R, Iishi H. Traction-assisted colonic endoscopic submucosal dissection using clip and line: a feasibility study. Endosc Int Open. 2016 Jan;4(1):E51-5. doi: 10.1055/s-0041-107779. Epub 2015 Nov 30.
- Background: PubMed 28254526Fuccio L, Hassan C, Ponchon T, Mandolesi D, Farioli A, Cucchetti A, Frazzoni L, Bhandari P, Bellisario C, Bazzoli F, Repici A. Clinical outcomes after endoscopic submucosal dissection for colorectal neoplasia: a systematic review and meta-analysis. Gastrointest Endosc. 2017 Jul;86(1):74-86.e17. doi: 10.1016/j.gie.2017.02.024. Epub 2017 Feb 28.
- Background: PubMed 24671869Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the primary publication may be shared upon reasonable request. Shared data may include participant characteristics, lesion characteristics, procedural variables, histopathologic outcomes, safety outcomes, and clinical course variables collected in this study.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Traction-Assisted Endoscopic Submucosal Dissection and Conventional Endoscopic Submucosal Dissection in people with Rectal Neuroendocrine Tumor, run by Pusan National University Hospital.
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 6 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seung Min Hong, M.D., Ph.D. (+82-51-240-7869, lucky77i@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resection speed (time frame: During the ESD procedure, from the start of submucosal dissection to complete lesion resection). 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 NCT07848360, which also lists 12 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 30 Sep 2026.