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

Postoperative Complications Clinical Trial

— FSI-TaTME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02943694
• Other study ID #: FT-001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: October 20, 2016
• Last updated: October 21, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Ruijin Hospital
• Contact: Jing Sun, Ph.D., M.D.
• Phone: 13524284622
• Email: jingsun1982[@]sina.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Complications
• Rectal Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	Shanghai Jiao Tong University School of Medicine

References & Publications (9)

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. — View Citation

Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11. Review. — View Citation

Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82. — View Citation

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. — View Citation

MacFarlane JK, Ryall RD, Heald RJ. Mesorectal excision for rectal cancer. Lancet. 1993 Feb 20;341(8843):457-60. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with post-operative complications	Number of participants with post-operative complications (e.g. numbers of postoperative bleeding, leakage, infections)	postoperative 30days (hospital-stay time course)	Yes
Secondary	3-year disease free survival rate	3-year disease free survival rate (the period after curative treatment without any detection of disease ), the detailed information of 3y-DFS will be obtained by period follow-up of patients by calls and outpatient checking.	postoperative 3years	No
Secondary	3-year overall survival rate	3-year overall survival rate (the survival period after curative treatment ), the detailed information of 3y-OS will be obtained by period follow-up of patients by calls and outpatient checking.	postoperative 3years	No