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Cola

Right colectomy Open surgery Central lymphadenectomy and vascular ligation

Right colectomy Laparoscopic surgery Central lymphadenectomy and vascular ligation

Open surgery

Right colectomy

Laparoscopic surgery

Central lymphadenectomy and vascular ligation

Kristin B. Lygre, M.D

The primary focus in this study is to investigate and improve the surgical technique. In addition the collection of clinical data during diagnostic and follow up and the collection of tumor and blood gives us the opportunity to investigate tumor biology and its relevance in terms of determine appropriate treatment strategy both surgically and oncological and to assess and predict treatment outcome.

The aim of this study is to compare short and long-term outcomes between open D3 and laparoscopic CME (complete mesocolic excision) with CVL (central vascular ligation) right colectomy for right-sided colon cancer. Our primary hypothesis is that laparoscopic surgery improves quality of life by reducing pain, postoperative complications and thereby reduces hospital stay and convalescence. On the other hand it is to prove non-inferiority of the laparoscopic group compared to the open group by means of oncological outcome (survival, recurrence). Secondary aim is to evaluate surgical quality by comparing actual vascular stump length between the two groups by postoperative CT and compare number of lymph nodes removed with the specimen. With the use of liquid biopsy we want to detect circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) and evaluate their value as tumor markers by comparing the prognostic and predictive value. The hypothesis is that ctDNA and CTCs are more sensitive than standard parameters and imaging (CT CEA).

This is a prospective, randomized, multi-center clinical study. The short term outcome, 2 and 5 year survival and mortality rates will be compared between the groups operated with open D3 resection at Haukeland University hospital and laparoscopic CME with CVL right hemicolectomy at Haraldsplass Deaconess hospital. Computer generated block randomization will be used.

All patients ≤ 85 years with tumor localized in the right colon will be considered to participate in the study. The patients will be summoned to the first consultation to the hospital they are referred to. They will be informed of the study. A patient who meets the inclusion criteria will be asked to participate in the study and sign the informed consent. A patient who accepts will be assigned a sequential participant number and then referred to open D3 or laparoscopic CME (right hemicolectomy) according to a pre-specified randomized list of treatments.

All patients referred with right sided colon cancer in the inclusion period will be registered, and the reason why some do not participate in the study will be documented. Patients who decline to participate in the study will be assigned standard treatment in the institution they are referred to.

Blood samples for analysis of ctDNA/CTCs will be collected preoperatively, 3-10th postoperative day, at 3 months and at each check the next five years at six months intervals. All sample times except the first postoperative control, correspond to the time of CEA and CT in ordinary follow-up. Proteomic technology based analysis of tumor tissue

Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer

Open D3 Right Colectomy Compared to Laparoscopic CME Right Colectomy for Right Sided Colon Cancer; an Open Randomized Controlled Study

Incidents of bleeding from central vascular structures; yes/no

Total length of stay, including readmissions within 30 days

Surgical and general complications by Clavien-Dindo Classification og surgical complications

15D Health-related quality of life (HRQoL) preoperative and at 6 months. Scale 0-1. a higher score reflects a better HRQoL

Quality of life (LARS (low anterior resection syndrome) score preoperative and at 6 months. Scale 0-42, where 0 reflects no LARS and 30-42 major LARS.

copies/mL plasma or % fractional abundance (mutant/total ctDNA)

Helse-Bergen HF

University of Bergen

Haraldsplass Deaconess Hospital

Consultant Doctor

Rare Diseases

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

D3 Lymphadenectomy involves surgical removal of lymph nodes from echelon or compartments 1 to 3 in gastric cancer patients

D3 Lymphadenectomy

Dr Shailesh V Shrikhande, MBBS MS MD

Dr Ashwin Luis Desouza, MBBS MS

Dr Shailesh v Shrikhande, MBBS MS MD

Dr Bhawna Sirohi, MBBS DCH

Dr.Ashwin L Desouza, MBBS MS

Dr Mukta Ramadwar, MBBS MD MRC

Dr Mahesh Goel, MBBS MS

Dr Shaesta Mehta, MBBS DNB MD

Dr Nitin shetty S Shetty, MBBS MD DNB

Dr Supreeta Arya, MD DNB DMRD

Dr Keadar Deodhar, MBBS MD MRC

Dr Munita Bal, MBBS MD DNB

Dr.Shraddha Patkar, MBBS MS

Dr.Abhishek Mitra, MBBS MS

Stomach cancer is the second most common cause of cancer-related deaths in India. Curative surgery offers the only chance of improving survival in this cancer. In patients whose cancer has not spread to other parts of the body (beyond the stomach and lymph nodes around it), removal of stomach (gastrectomy) with lymph nodes around the stomach and along the major vessels supplying blood to the stomach (D2 lymphadenectomy) is regarded as current standard of care at Tata Memorial Centre. However, the extent of lymphadenectomy is controversial. Some studies have suggested that removing more lymph nodes, even around the major vessels of the abdomen (aorta and inferior vena cava) may not only help to accurately determine the disease spread, but may also confer an additional survival benefit. Removing more lymph nodes around the major vessels may increase the risk of morbidity to the patient.

In the last 5-6 years, stomach cancer specialists around the world have resorted to giving half the cycles of chemotherapy to the patient before the surgery (neoadjuvant chemotherapy), and the other half after the surgery in what is called 'perioperative chemotherapy'. This has been shown to lead to more patients surviving to 5 years, than before.

The investigators feel that perioperative chemotherapy with D2 lymphadenectomy may constitute the best care for our patients with stomach cancer such that no further removal of lymph nodes beyond is required. However, the investigators have no evidence in literature to support this hypothesis. The investigators have thus designed this trial based on which we propose that there exists no difference between a D2 lymphadenectomy and a D3 lymphadenectomy following neoadjuvant chemotherapy for non-metastatic, locally advanced but resectable gastric cancer. The data will enable the development of clear management guidelines for lymph node dissection in stomach cancer.

The only data comparing D2 and D3 comes from a multi-institutional, non-randomised study which reported that D3 lymphadenectomy conferred a survival advantage over D2 in tumours that were 50-100mm in diameter, with or without lymph nodal disease.

Of the three published randomised controlled trials(RCT) comparing D2 versus D2+paraaortic nodal dissection (PAND), two of the studies in which the long-term results are available, were carried out in Japan. In both these studies, the patients were not offered chemotherapy until after they developed a recurrence. Another reason is the benefit on survival, albeit modest, in patients undergoing D3 lymphadenectomy that has been noted in the study by Wu et al.

Another important reason for comparing D2 versus D2+PAND, lies in the fact that none of the aforementioned RCTs have been performed after the 1998 revision in the definition of lymph node stations by the Japanese Gastric cancer association. Hence, none of these results can be considered representative of the current classifications.

Duly considering the possible higher morbidity that has been shown with a complete para aortic lymph node dissection, the investigators propose to study a more extensive lymphadenectomy than D2 but without increasing the risk of morbidity in the patient.

D2 lymphadenectomy has been performed at Tata Memorial Centre (TMC), since 2002 with morbidity and mortality rates comparable to world literature It is the standard form of lymphadenectomy in TMC. Hence, the trial will be performed by surgeons experienced in the technique. D3 is performed in some centres in Japan, Italy and Taiwan (where the only randomized controlled trial demonstrated a survival benefit of D3 over D1). Both the procedures are well established and regarded as standards in different parts of the world.

Gastrectomy with D2 or D3 lymphadenectomy

"Phase III Randomized Trial Comparing D2 vs D3 Lymphadenectomy With Gastric Cancer Following Neoadjuvant Chemotherapy

Phase III Randomized Controlled Trial Comparing D2 Versus D3 Lymphadenectomy on Outcomes of Non-metastatic, Resectable, But Locally Advanced, Gastric Cancer Following Neoadjuvant (Perioperative) Chemotherapy (ELANCe Trial)

overall survival will be calculated from randomization to death.

Disease-free survival will be calculated from definitive resection to the first event (i.e., local recurrence, distant recurrence, or death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer	NCT03776591	Complication Quality of Life Surgical Proced... Lymph Node Meta... Circulating Tum...	Open surgery Right colectomy Laparoscopic su... Central lymphad...	18 Years - 85 Years	Haraldsplass Deaconess Hospital
"Phase III Randomized Trial Comparing D2 vs D3 Lymphadenectomy With Gastric Cancer Following Neoadjuvant Chemotherapy	NCT02139605	Gastric Cancer	D3 Lymphadenect...	18 Years - 85 Years	Tata Memorial Centre
"Phase III Randomized Trial Comparing D2 vs D3 Lymphadenectomy With Gastric Cancer Following Neoadjuvant Chemotherapy	NCT02139605	Gastric Cancer	D3 Lymphadenect...	18 Years - 85 Years	Tata Memorial Centre

Spots Global Cancer Trial Database for d3 lymphadenectomy