Study Results
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Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2015-06-30
2020-04-30
Brief Summary
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Detailed Description
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Complete mesocolic excision (CME) for colon cancer was reemphasized, with the merits of providing better cancer clearance and higher 5 year survival rate. Recently, it has been reported that patients with or without lymph node metastasis both benefit from a wider mesenteric excision including as many negative lymph nodes as possible. The use of D3 lymphadenectomy in colon cancer has been the state of art for decade in Asian countries. A comparison between Japanese D3 resection and European CME with central vascular ligation (CVL) showed that both series were oncologically superior to the traditional right hemicolectomy. Most recently, a consensus is reached between European and Japanese experts that a more radical approach combining CME and D3 lymphadenectomy are oncologically preferable.
Laparoscopic right hemicolectomy with CME or D3 lymphadenectomy have been reported to be feasible and safe by several authors. However, due to the notorious high rate of vascular variations in right colon, laparoscopic right-sided CME with CVL or D3 resection in obese patient remains challenging, even at experienced hands. Two of the major technical difficulties include the identifying of superior mesenteric vein (SMV) in thick layer of fatty tissue and dissection around the middle colic vessels. Here the investigators report a novel technique to tackle these two problems by combining transection of the bowels through the small incision and a medial to lateral approach of hand-assisted laparoscopic (HAL) surgery. The details are as followed:
Surgical Techniques Operation steps outside the abdominal cavity Under general anesthesia, the patient was placed in the supine position with legs split-ted. A middle incision about 7 centimeters long was made around the umbilicus, which was used for placing Lapdisc. This procedure started with transection of great omentum, transverse colon and the distal ileum through the self-expandible Lapdisc.
Transect transverse colon For cancer at ascending colon or cecum, the transverse colon should be divided at a site between the left and right branches of middle colic artery. For hepatic flexural or transverse colon cancer, the transverse colon should be divided at the left side of middle colic artery. After transverse colon was divided, the two ends of transverse colon were returned into the abdomen.
Transect distal ileum Distal ileum was transected 15 to 25 cm from ileocecal valve. After that, the distal end of superior mesenteric vessels were easily identified and severed. By holding the stump, dissection around the superior mesenteric artery (SMA) and SMV could be easily achieved and advanced up to the level of duodenum. And in most cases, the ileocolic artery and vein could be cut at their origins through this small incision. Then, the bowel was returned.
Establish pneumoperitoneum Three trocars were engaged for this procedure: port A was in the left lower quadrant as the main working port; port B was in the upper left quadrant for camera port; and port C was slightly below the xiphoid and used mainly for retracting the mesocolon or the stomach. Next, the Lapdisc was placed and pneumoperitoneum with a pressure of 10-12 mmHg was established.
D3 lymph node dissection with CME and CVL The D3 lymphadenectomy and mobilization of colon were then performed intracorporeally. The course of lymphadenectomy was divided into four steps.
First: Cut peritoneum over SMA and identified the pancreatic neck The surgeon held the middle colic vessels and pulled the mesentery ventrally and finished dividing the mesocolon to ensure a direct view of the pancreatic neck. Open the peritoneum over the SMA and advance cephalad till the pancreas was exposed.
Second: Serving of arterial branches to right colon To identify the arterial branches that cross over the SMV to supply the right sided colon, cares must be taken to take a very thin slice of fat tissue between two blades of Harmonic with the inactive blade facing the SMV, and not to take a big bite of tissue in one time to avoid involving the vessel itself. Before dealing with the middle colic artery, it was better to expose the dorsal edge of pancreatic neck which also marks the anterior level of SMV. Then, both the right colic and middle colic artery were identified. With the help of a finger, it was much easier to push the forcep through behind a vessel and apply ham-locks to the origin of the middle colic artery and the right colic artery. Then the two arteries were divided.
Third: Serving of venous branches from the colon After exposure of the whole length of SMV, the middle colic vein was likely to show itself without much dissection. The middle colic vein was clipped and divided. Then dissect along the right side of SMV. The ileocolic vein had already been divided. The right colic vein, which drains into SMV directly, was clipped and divided. Then dissect along the pancreatic neck.
Fourth: Dissection in front of the pancreatic head. Dissection was continued cephalad, the gastroepiploic vein was observed before dealing with it, and the pancreatic head was exposed. Dissection in front of anterior pancreatoduodenal fascia and blunt dissection was employed for separation mesocolon from the Toldt's fascia.
Mobilization of the right colon With the finger providing constantly changing counter-retraction, the mobilization of mesocolon could be carried out in a fast and precise manner. Mobilizing the cecum from behind the mesocolon called for the surgeon to turn his hand with the palm facing ventrally, and the camera holder turned the camera rod to view mesocolon from behind. Because all the vessels feeding the right sided colon as well as the marginal artery had been severed, the tumor was bloodless during the mobilization of colon. Last, dissect the gastrocolic ligament. For patients with an ascending colon cancer, the gastroepiploic vessels were preserved. With a good retraction provided by hand, the mobilization of mesocolon was an easy task after the medial approach dissection.
Anastomosis After right colon was excised, a side-to-side ileocolic anastomosis was created, and the mesenteric defect was closed extra-corporeally through the small incision.
According to our previous study, this novel HAL right hemicolectomy with CME and CVL is technically feasible and safe. This novel technique carries the merit of blocking all the blood supply to the colon before the mobilization of the tumor and is more in line with the "no touch isolation" technique.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
The novel hand-assisted laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were brought out through the hand-port incision at the beginning of the operation and divided extracorporeally.
Group A
The novel hand-assisted laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were brought out through the hand-port incision at the beginning of the operation and divided extracorporeally.
Group B
novel laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were divided at the beginning of the operation intracorporeally.
No interventions assigned to this group
Group C
the traditional laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer.
No interventions assigned to this group
Interventions
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Group A
The novel hand-assisted laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were brought out through the hand-port incision at the beginning of the operation and divided extracorporeally.
Eligibility Criteria
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Inclusion Criteria
* Clinical stage: I, II, III
* No preoperative chemoradiotherapy
* No past surgical history
* No serious preoperative complication
* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
* Age: 18-80
* Written informed consent
Exclusion Criteria
* Metastatic cancer
* Multiple cancer
* Serious complications (including bowel perforation, bowel obstruction, gastrointestinal hemorrhage)
* Pregnant and lactating women
* Psychological disorder
* Steroid administration
* Cardiac infarction within six months
* Severe pulmonary emphysema and pulmonary fibrosis
18 Years
80 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Ziqiang Wang,MD
Chief of Department of Gastrointestinal Surgery
Principal Investigators
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Ziqiang Wang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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West China hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Ziqiang Wang, PhD,MD
Role: primary
Xuyang Yang, MD
Role: backup
References
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Veldkamp R, Kuhry E, Hop WC, Jeekel J, Kazemier G, Bonjer HJ, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy AM; COlon cancer Laparoscopic or Open Resection Study Group (COLOR). Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial. Lancet Oncol. 2005 Jul;6(7):477-84. doi: 10.1016/S1470-2045(05)70221-7.
Colon Cancer Laparoscopic or Open Resection Study Group; Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009 Jan;10(1):44-52. doi: 10.1016/S1470-2045(08)70310-3. Epub 2008 Dec 13.
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Chung CC, Ng DC, Tsang WW, Tang WL, Yau KK, Cheung HY, Wong JC, Li MK. Hand-assisted laparoscopic versus open right colectomy: a randomized controlled trial. Ann Surg. 2007 Nov;246(5):728-33. doi: 10.1097/SLA.0b013e318123fbdf.
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Handoscopic surgery: a prospective multicenter trial of a minimally invasive technique for complex abdominal surgery. Southern Surgeons' Club Study Group. Arch Surg. 1999 May;134(5):477-85; discussion 485-6.
Hohenberger W, Weber K, Matzel K, Papadopoulos T, Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation--technical notes and outcome. Colorectal Dis. 2009 May;11(4):354-64; discussion 364-5. doi: 10.1111/j.1463-1318.2008.01735.x. Epub 2009 Nov 5.
Petrovic T, Radovanovic Z, Breberina M, et al. Complete mesocolic excision with central supplying vessel ligation- new technique in colon cancer treatment. Arch Oncol, 2010; 18(3) : 84- 85.
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West NP, Morris EJ, Rotimi O, Cairns A, Finan PJ, Quirke P. Pathology grading of colon cancer surgical resection and its association with survival: a retrospective observational study. Lancet Oncol. 2008 Sep;9(9):857-65. doi: 10.1016/S1470-2045(08)70181-5. Epub 2008 Jul 28.
West NP, Kobayashi H, Takahashi K, Perrakis A, Weber K, Hohenberger W, Sugihara K, Quirke P. Understanding optimal colonic cancer surgery: comparison of Japanese D3 resection and European complete mesocolic excision with central vascular ligation. J Clin Oncol. 2012 May 20;30(15):1763-9. doi: 10.1200/JCO.2011.38.3992. Epub 2012 Apr 2.
Feng B, Sun J, Ling TL, Lu AG, Wang ML, Chen XY, Ma JJ, Li JW, Zang L, Han DP, Zheng MH. Laparoscopic complete mesocolic excision (CME) with medial access for right-hemi colon cancer: feasibility and technical strategies. Surg Endosc. 2012 Dec;26(12):3669-75. doi: 10.1007/s00464-012-2435-9. Epub 2012 Jun 26.
Adamina M, Manwaring ML, Park KJ, Delaney CP. Laparoscopic complete mesocolic excision for right colon cancer. Surg Endosc. 2012 Oct;26(10):2976-80. doi: 10.1007/s00464-012-2294-4. Epub 2012 May 2.
Takemasa I, Uemura M, Nishimura J, Mizushima T, Yamamoto H, Ikeda M, Sekimoto M, Doki Y, Mori M. Feasibility of single-site laparoscopic colectomy with complete mesocolic excision for colon cancer: a prospective case-control comparison. Surg Endosc. 2014 Apr;28(4):1110-8. doi: 10.1007/s00464-013-3284-x. Epub 2013 Nov 8.
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BARNES JP. Physiologic resection of the right colon. Surg Gynecol Obstet. 1952 Jun;94(6):722-6. No abstract available.
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Wiggers T, Jeekel J, Arends JW, Brinkhorst AP, Kluck HM, Luyk CI, Munting JD, Povel JA, Rutten AP, Volovics A, et al. No-touch isolation technique in colon cancer: a controlled prospective trial. Br J Surg. 1988 May;75(5):409-15. doi: 10.1002/bjs.1800750505.
Yang X, Wu Q, Jin C, He W, Wang M, Yang T, Wei M, Deng X, Meng W, Wang Z. A novel hand-assisted laparoscopic versus conventional laparoscopic right hemicolectomy for right colon cancer: study protocol for a randomized controlled trial. Trials. 2017 Jul 26;18(1):355. doi: 10.1186/s13063-017-2084-3.
Other Identifiers
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HALS-CME 201512
Identifier Type: -
Identifier Source: org_study_id