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

NCT02943694 | Unknown Phase 1 DMC

• 1 other identifier: FT-001
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Postoperative Complications

Keywords

TaTME; Complications; Instrument

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• 3-year disease free survival rate

  postoperative 3years

• 3-year overall survival rate

  postoperative 3years

Study Arms (1)

TaTME with CS-Compact (GelPoint Path)

EXPERIMENTAL

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

Device: TaTME with CS-Compact (GelPoint pathway)

Interventions

TaTME with CS-Compact (GelPoint pathway) DEVICE

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

TaTME with CS-Compact (GelPoint Path)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

Related Publications (9)

• 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.

  PMID: 24639052 BACKGROUND

• 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.

  PMID: 24225001 BACKGROUND

• 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.

  PMID: 2425199 BACKGROUND

• 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.

  PMID: 8094488 BACKGROUND

• 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.

  PMID: 26659246 BACKGROUND

• 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.

  PMID: 22752277 BACKGROUND

• 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.

  PMID: 20174935 BACKGROUND

• 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.

  PMID: 27333465 BACKGROUND

• 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.

  PMID: 25633642 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei-Guo HU, Ph.D., M.D.

  Ruijin Hospital

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

13524284622; jingsun1982@sina.cn

Jian-qing YAO, Ph.D.

CONTACT

13681815601; JIANMARIA@HOTMAIL.COM

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 25, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: October 25, 2016

Record last verified: 2016-10