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The Feasibility and Safety of Instruments in Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer

NCT ID: NCT02943694

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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Colorectal cancer is one of the leading deadly diseases in the world. Due to the TME (total mesorectal excision) for the last decades, the survival and relapse rate of rectal cancer patients have been considerably improved. However, anatomical limitations in pelvic space hinder the further optimization of surgical treatment Thus, the natural orifice transluminal endoscopic surgery (NOTES) emerges as an alternative surgical strategy. Of note, transanal total mesorectal excision (TaTME) , a new invention based on TME principle, NOTES conception and single port technique, has been prevailing both in West and East nations, with or without the abdominal laparoscopic assistance. Up to date, there are various kinds of instruments and patterns to complete TaTME with comparable clinical outcomes. However, flaws in each instrument remains according to the feedbacks. This study is therefore designed to clinically evaluate the feasibility and safety of the new instruments specifically for TaTME (CS-Compact, GelPoint pathway).

Detailed Description

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Rectal cancer comprises the most in colorectal cancer around the world, among which surgery remains the optimal therapeutic intervention. The TME (Total Mesorectal Excision), proposed by Bill Heald, provides novel insights for the eradication of possible disseminated cancer cells and therefore reduces the recurrence and mortality rates. However, either laparoscopic or open TME surgery is limited by the pelvic space and further improvement. For the last decade, the emerging of the natural orifice transluminal endoscopic surgery (NOTES) offers an alternative pattern for rectal cancer surgery, among which, the TaTME (transanal total mesorectal excision) represents the most optimized surgery techniques. Derived from TME, NOTES and modified laparoscopic instruments, TaTME facilitates the dissection process of rectal cancer from caudal to cranial, from indirect to direct vision. TaTME allows for accurate confirmation of resected margin with proper transecting level, better dissection of mesorectum and protection of sphincter, a qualified end-to-end anastomosis and reduced need of endolinear stapler and possible leakage afterwards. However, various kinds of instruments and surgical procedures have been proposed to complete TaTME, all of which have been validated by preclinical and clinical trials in small size. Of note, this study is initiated to apply a suit of instruments specifically designed for TaTME ( GelPoint pathway CS-Compact) and clinically evaluate the feasibility and safety of the new instruments without comparison to other prevailing ones. The CS-Compact and GelPoint pathway has been confirmed both safe and feasible to operate in preclinical trials and clinical trials in western. This study strictly examines the corresponding issues in Chinese rectal cancer patients. The surgeons in our institute have successfully completed the training programs of TaTME in preclinical trials, in animal models and cadavers. Clinical skills and knowledge to safe operations are qualified.

Conditions

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Postoperative Complications

Keywords

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TaTME Complications Instrument

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TaTME with CS-Compact (GelPoint Path)

Based on newly-designed devices tailored for transanal TME, CS-Compact, GelPoint and Octoport are employed for the clinical applications.

Group Type EXPERIMENTAL

TaTME with CS-Compact (GelPoint pathway)

Intervention Type DEVICE

Standard TaTME with circular stapler (Short and straight, CS Compact), designed for extra-corporeal and endo-anal anastomosis procedures.

Interventions

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TaTME with CS-Compact (GelPoint pathway)

Standard TaTME with circular stapler (Short and straight, CS Compact), designed for extra-corporeal and endo-anal anastomosis procedures.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* rectal cancer patients, confirmed by the endoscopic biopsy;
* curative rectal cancer in clinical stage with resectable lesion, the cTNM stage \<T3 stage, with comparable tumor size in low or medial rectum.
* patients' general information, 18ys\<age\<75ys, no restriction in genders, BMI\< or =30kg/m2, no presentation of severe chronic diseases (i.e. COPD), WHO classification \<2 (Zubrod-ECOG-WHO)
* patients or representatives have agreed and signed the informed consent documents.

Exclusion Criteria

* have received neo-adjuvant chemotherapy or radiotherapy before operations;
* previous surgery in pelvis
* uncontrollable diseases such as diseases in cardiopulmonary function, chronic bronchitis, severe hepatitis/diabetes/malnutrition/renal function.
* suffer from other malignant diseases, i.e. gastric cancer, liver cancer.
* pregnant, lactation stage.
* metal disorders.
* lacking qualified compliance.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weiguo Hu

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei-Guo HU, Ph.D., M.D.

Role: STUDY_DIRECTOR

Ruijin Hospital

Central Contacts

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Jing Sun, Ph.D., M.D.

Role: CONTACT

Phone: 13524284622

Email: [email protected]

Jian-qing YAO, Ph.D.

Role: CONTACT

Phone: 13681815601

Email: [email protected]

References

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Siegel R, Desantis C, Jemal A. Colorectal cancer statistics, 2014. CA Cancer J Clin. 2014 Mar-Apr;64(2):104-17. doi: 10.3322/caac.21220. Epub 2014 Mar 17.

Reference Type BACKGROUND
PMID: 24639052 (View on PubMed)

Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11.

Reference Type BACKGROUND
PMID: 24225001 (View on PubMed)

Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82. doi: 10.1016/s0140-6736(86)91510-2.

Reference Type BACKGROUND
PMID: 2425199 (View on PubMed)

MacFarlane JK, Ryall RD, Heald RJ. Mesorectal excision for rectal cancer. Lancet. 1993 Feb 20;341(8843):457-60. doi: 10.1016/0140-6736(93)90207-w.

Reference Type BACKGROUND
PMID: 8094488 (View on PubMed)

McLemore EC, Harnsberger CR, Broderick RC, Leland H, Sylla P, Coker AM, Fuchs HF, Jacobsen GR, Sandler B, Attaluri V, Tsay AT, Wexner SD, Talamini MA, Horgan S. Transanal total mesorectal excision (taTME) for rectal cancer: a training pathway. Surg Endosc. 2016 Sep;30(9):4130-5. doi: 10.1007/s00464-015-4680-1. Epub 2015 Dec 10.

Reference Type BACKGROUND
PMID: 26659246 (View on PubMed)

Telem DA, Han KS, Kim MC, Ajari I, Sohn DK, Woods K, Kapur V, Sbeih MA, Perretta S, Rattner DW, Sylla P. Transanal rectosigmoid resection via natural orifice translumenal endoscopic surgery (NOTES) with total mesorectal excision in a large human cadaver series. Surg Endosc. 2013 Jan;27(1):74-80. doi: 10.1007/s00464-012-2409-y. Epub 2012 Jun 30.

Reference Type BACKGROUND
PMID: 22752277 (View on PubMed)

Atallah S, Albert M, Larach S. Transanal minimally invasive surgery: a giant leap forward. Surg Endosc. 2010 Sep;24(9):2200-5. doi: 10.1007/s00464-010-0927-z. Epub 2010 Feb 21.

Reference Type BACKGROUND
PMID: 20174935 (View on PubMed)

Kneist W, Hanke L, Kauff DW, Lang H. Surgeons' assessment of internal anal sphincter nerve supply during TaTME - inbetween expectations and reality. Minim Invasive Ther Allied Technol. 2016 Oct;25(5):241-6. doi: 10.1080/13645706.2016.1197269. Epub 2016 Jun 22.

Reference Type BACKGROUND
PMID: 27333465 (View on PubMed)

Muratore A, Mellano A, Marsanic P, De Simone M. Transanal total mesorectal excision (taTME) for cancer located in the lower rectum: short- and mid-term results. Eur J Surg Oncol. 2015 Apr;41(4):478-83. doi: 10.1016/j.ejso.2015.01.009. Epub 2015 Jan 17.

Reference Type BACKGROUND
PMID: 25633642 (View on PubMed)

Other Identifiers

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FT-001

Identifier Type: -

Identifier Source: org_study_id