Pancreatic CancerNCT03792932
Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer
A study testing Laparoscopic distal pancreatectomy and Open distal pancreatectomy in people with Pancreatic Cancer and Surgery, run by Fudan University at 11 sites in China.
Trial summary
Open distal pancreatectomy (ODP) has been commonly employed for the treatment of a variety of cancers in body and tail of pancreas. Although many general surgical procedures have been increasingly performed laparoscopically or with laparoscopic assistance, until the current decade, laparoscopic pancreatic surgery had… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Pancreatic Cancer, Surgery, Laparoscopy
- What is being tested?
- Laparoscopic distal pancreatectomy and Open distal pancreatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 11 sitesChina
- Study dates
- 2 Feb 2019to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years and ≤ 80 years, no gender limitation
- Resectable body and tail pancreatic cancer (refer to NCCN 2018)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Tumor locates at the body and tail of the pancreas without distant metastasis
- No celiac trunk and superior mesenteric artery invasion
- No operation contraindication, fit for laparoscopic surgery
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- The expected survival after surgery ≥ 3 months
- Patients who are willing and able to comply with the study procedure
- Signed informed content obtained prior to treatment
Who cannot join
- Locally advanced unresectable body and tail pancreatic cancer
- Multi-organ and vascular resection needed
- Patients undergoing total pancreatectomy
- Benign tumor at the body and tail of the pancreas or pancreatic cancer at the head of the pancreas
- Distant metastasis or ascites detected by imaging
- Severe important organ function impairment (heart, liver, kidney)
Show all 10Show fewer
- Patients who are with other primary malignancy or haematological disorders
- Pregnant or nursing women
- Patients who have received chemotherapy, radiotherapy and interventional therapy before the pancreatectomy
- Patients who have participated in other clinical trials for pancreatic cancer treatment within 3 months
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Yunqiang Cai, Dr., 17721950223, 494374409@qq.com
- Recruiting
Department of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People's Hospital
Hanzhou, Zhejiang
Weiwei Jin
- Recruiting
Department of Hepatopancreatobiliary Surgery, Second Affiliated Hospital of Harbin Medical University,
Harbin, Heilongjiang
Zhidong Wang, wangzhidong@hrbmu.edu.cn
- Recruiting
Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University
Harbin
Hua Chen
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui
chenlin zhu
- Recruiting
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, China
Shanghai, Shanghai Municipality, 200032
Xianjun Yu, M.D., Ph.D., +86-21-6417-5590 ext. 1307, yuxianjun@fudanpci.org
He Cheng, M.D., Ph.D., +86-21-6417-5590 ext. 1307, chenghe@fudanpci.org
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Liang Tang, Dr., 13918874380, tlehbh@126.com
- Recruiting
Department of Biliopancreatic Surgery, Huadong Hospital, Fudan University
Shanghai
Wei Wang, wangw2003cn@126.com
- Recruiting
Department of Hepatobiliary and Pancreatic Surgery, The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Jianhua Liu
- Recruiting
Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Renyi Qin, PHD, ryqin@tjh.tjmu.edu.cn
- Recruiting
Department of Hepato-Pancreato-Biliary Surgery, The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Wenxing Zhao
About this study
Official title: A Multicenter Prospective RCT Study of Laparoscopic Versus Open Distal Pancreatectomy in Patients With Pancreatic Cancer at the Body and Tail
Open distal pancreatectomy (ODP) has been commonly employed for the treatment of a variety of cancers in body and tail of pancreas. Although many general surgical procedures have been increasingly performed laparoscopically or with laparoscopic assistance, until the current decade, laparoscopic pancreatic surgery had not been performed for its complicated anatomy. But laparoscopic distal pancreatectomy (LDP) has been widely accepted as a standard treatment for body and tail pancreatic cancer because there is no anastomosis in it, and LDP has gradually become the first choice for these cancers in clinical work. Although there are several studies about the comparison between LDP and ODP, most are retrospective and there is no agreement in surgical margin, lymph node numbers and prognosis to identify the oncological differences between the two surgical approaches. The investigators' pilot study showed that patients with body and tail pancreatic cancer underwent LDP had a better prognosis compared with the ones undergoing ODP, with no statistics differences in postoperative complications and mortality. This perspective RCT study is performed to confirm whether LDP would improve the prognosis for patients with body and tail pancreatic cancer compared with ODP.
- Conditions
- Pancreatic Cancer, Surgery, Laparoscopy
- Being tested
- Laparoscopic distal pancreatectomy, Open distal pancreatectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic distal pancreatectomyProcedure or surgery
Laparoscopic distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
Open distal pancreatectomyProcedure or surgery
Open distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic distal pancreatectomy | Active comparator | Not described Receives: Procedure: Laparoscopic distal pancreatectomy |
| Open distal pancreatectomy | Active comparator | Not described Receives: Procedure: Open distal pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival
RFS
Measured: 2 years
Secondary outcomes (3)
Overall Survival
OS
Measured: 2 years
R0 resection rate
R0 resection rate
Measured: 2 years
Detected lymph node number
Detected lymph node number
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start2 Feb 2019
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792932
- Sponsor's protocol ID
- CSPAC-2
- Status last verified
- Jun 2022
- First submitted
- 27 Dec 2018
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ricci C, Casadei R, Taffurelli G, Toscano F, Pacilio CA, Bogoni S, D'Ambra M, Pagano N, Di Marco MC, Minni F. Laparoscopic versus open distal pancreatectomy for ductal adenocarcinoma: a systematic review and meta-analysis. J Gastrointest Surg. 2015 Apr;19(4):770-81. doi: 10.1007/s11605-014-2721-z. Epub 2015 Jan 6.
PubMed 25560180van Hilst J, de Rooij T, Klompmaker S, Rawashdeh M, Aleotti F, Al-Sarireh B, Alseidi A, Ateeb Z, Balzano G, Berrevoet F, Bjornsson B, Boggi U, Busch OR, Butturini G, Casadei R, Del Chiaro M, Chikhladze S, Cipriani F, van Dam R, Damoli I, van Dieren S, Dokmak S, Edwin B, van Eijck C, Fabre JM, Falconi M, Farges O, Fernandez-Cruz L, Forgione A, Frigerio I, Fuks D, Gavazzi F, Gayet B, Giardino A, Groot Koerkamp B, Hackert T, Hassenpflug M, Kabir I, Keck T, Khatkov I, Kusar M, Lombardo C, Marchegiani G, Marshall R, Menon KV, Montorsi M, Orville M, de Pastena M, Pietrabissa A, Poves I, Primrose J, Pugliese R, Ricci C, Roberts K, Rosok B, Sahakyan MA, Sanchez-Cabus S, Sandstrom P, Scovel L, Solaini L, Soonawalla Z, Souche FR, Sutcliffe RP, Tiberio GA, Tomazic A, Troisi R, Wellner U, White S, Wittel UA, Zerbi A, Bassi C, Besselink MG, Abu Hilal M; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Minimally Invasive versus Open Distal Pancreatectomy for Ductal Adenocarcinoma (DIPLOMA): A Pan-European Propensity Score Matched Study. Ann Surg. 2019 Jan;269(1):10-17. doi: 10.1097/SLA.0000000000002561.
PubMed 29099399Sulpice L, Farges O, Goutte N, Bendersky N, Dokmak S, Sauvanet A, Delpero JR; ACHBT French Pancreatectomy Study Group. Laparoscopic Distal Pancreatectomy for Pancreatic Ductal Adenocarcinoma: Time for a Randomized Controlled Trial? Results of an All-inclusive National Observational Study. Ann Surg. 2015 Nov;262(5):868-73; discussion 873-4. doi: 10.1097/SLA.0000000000001479.
PubMed 26583678Shin SH, Kim SC, Song KB, Hwang DW, Lee JH, Lee D, Lee JW, Jun E, Park KM, Lee YJ. A comparative study of laparoscopic vs. open distal pancreatectomy for left-sided ductal adenocarcinoma: a propensity score-matched analysis. J Am Coll Surg. 2015 Feb;220(2):177-85. doi: 10.1016/j.jamcollsurg.2014.10.014. Epub 2014 Oct 31.
PubMed 25529901Venkat R, Edil BH, Schulick RD, Lidor AO, Makary MA, Wolfgang CL. Laparoscopic distal pancreatectomy is associated with significantly less overall morbidity compared to the open technique: a systematic review and meta-analysis. Ann Surg. 2012 Jun;255(6):1048-59. doi: 10.1097/SLA.0b013e318251ee09.
PubMed 22511003
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective RCT Study of Laparoscopic Versus Open Distal Pancreatectomy in Patients With Pancreatic Cancer at the Body and Tail
- ClinicalTrials.gov ID
- NCT03792932
- Acronym / sponsor ID
- CSPAC-2
- Conditions
- Pancreatic Cancer, Surgery, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open distal pancreatectomy (ODP) has been commonly employed for the treatment of a variety of cancers in body and tail of pancreas. Although many general surgical procedures have been increasingly performed laparoscopically or with laparoscopic assistance, until the current decade, laparoscopic pancreatic surgery had not been performed for its complicated anatomy. But laparoscopic distal pancreatectomy (LDP) has been widely accepted as a standard treatment for body and tail pancreatic cancer because there is no anastomosis in it, and LDP has gradually become the first choice for these cancers in clinical work. Although there are several studies about the comparison between LDP and ODP, most are retrospective and there is no agreement in surgical margin, lymph node numbers and prognosis to identify the oncological differences between the two surgical approaches. The investigators' pilot study showed that patients with body and tail pancreatic cancer underwent LDP had a better prognosis compared with the ones undergoing ODP, with no statistics differences in postoperative complications and mortality. This perspective RCT study is performed to confirm whether LDP would improve the prognosis for patients with body and tail pancreatic cancer compared with ODP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic distal pancreatectomy | Active comparator | Procedure: Laparoscopic distal pancreatectomy |
| Open distal pancreatectomy | Active comparator | Procedure: Open distal pancreatectomy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 19 years and ≤ 80 years, no gender limitation
- Resectable body and tail pancreatic cancer (refer to NCCN 2018)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Tumor locates at the body and tail of the pancreas without distant metastasis
- No celiac trunk and superior mesenteric artery invasion
Key exclusion criteria (10 listed)
- Locally advanced unresectable body and tail pancreatic cancer
- Multi-organ and vascular resection needed
- Patients undergoing total pancreatectomy
- Benign tumor at the body and tail of the pancreas or pancreatic cancer at the head of the pancreas
- Distant metastasis or ascites detected by imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic distal pancreatectomyLaparoscopic distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS). | Procedure or surgery | Laparoscopic distal pancreatectomy |
| Open distal pancreatectomyOpen distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS). | Procedure or surgery | Open distal pancreatectomy |
Primary outcome
Recurrence Free Survival
Time frame: 2 years
RFS
3 secondary outcomes
Overall Survival
Time frame: 2 years
R0 resection rate
Time frame: 2 years
Detected lymph node number
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Background: PubMed 25560180Ricci C, Casadei R, Taffurelli G, Toscano F, Pacilio CA, Bogoni S, D'Ambra M, Pagano N, Di Marco MC, Minni F. Laparoscopic versus open distal pancreatectomy for ductal adenocarcinoma: a systematic review and meta-analysis. J Gastrointest Surg. 2015 Apr;19(4):770-81. doi: 10.1007/s11605-014-2721-z. Epub 2015 Jan 6.
- Background: PubMed 29099399van Hilst J, de Rooij T, Klompmaker S, Rawashdeh M, Aleotti F, Al-Sarireh B, Alseidi A, Ateeb Z, Balzano G, Berrevoet F, Bjornsson B, Boggi U, Busch OR, Butturini G, Casadei R, Del Chiaro M, Chikhladze S, Cipriani F, van Dam R, Damoli I, van Dieren S, Dokmak S, Edwin B, van Eijck C, Fabre JM, Falconi M, Farges O, Fernandez-Cruz L, Forgione A, Frigerio I, Fuks D, Gavazzi F, Gayet B, Giardino A, Groot Koerkamp B, Hackert T, Hassenpflug M, Kabir I, Keck T, Khatkov I, Kusar M, Lombardo C, Marchegiani G, Marshall R, Menon KV, Montorsi M, Orville M, de Pastena M, Pietrabissa A, Poves I, Primrose J, Pugliese R, Ricci C, Roberts K, Rosok B, Sahakyan MA, Sanchez-Cabus S, Sandstrom P, Scovel L, Solaini L, Soonawalla Z, Souche FR, Sutcliffe RP, Tiberio GA, Tomazic A, Troisi R, Wellner U, White S, Wittel UA, Zerbi A, Bassi C, Besselink MG, Abu Hilal M; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Minimally Invasive versus Open Distal Pancreatectomy for Ductal Adenocarcinoma (DIPLOMA): A Pan-European Propensity Score Matched Study. Ann Surg. 2019 Jan;269(1):10-17. doi: 10.1097/SLA.0000000000002561.
- Background: PubMed 26583678Sulpice L, Farges O, Goutte N, Bendersky N, Dokmak S, Sauvanet A, Delpero JR; ACHBT French Pancreatectomy Study Group. Laparoscopic Distal Pancreatectomy for Pancreatic Ductal Adenocarcinoma: Time for a Randomized Controlled Trial? Results of an All-inclusive National Observational Study. Ann Surg. 2015 Nov;262(5):868-73; discussion 873-4. doi: 10.1097/SLA.0000000000001479.
- Background: PubMed 25529901Shin SH, Kim SC, Song KB, Hwang DW, Lee JH, Lee D, Lee JW, Jun E, Park KM, Lee YJ. A comparative study of laparoscopic vs. open distal pancreatectomy for left-sided ductal adenocarcinoma: a propensity score-matched analysis. J Am Coll Surg. 2015 Feb;220(2):177-85. doi: 10.1016/j.jamcollsurg.2014.10.014. Epub 2014 Oct 31.
- Background: PubMed 22511003Venkat R, Edil BH, Schulick RD, Lidor AO, Makary MA, Wolfgang CL. Laparoscopic distal pancreatectomy is associated with significantly less overall morbidity compared to the open technique: a systematic review and meta-analysis. Ann Surg. 2012 Jun;255(6):1048-59. doi: 10.1097/SLA.0b013e318251ee09.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic distal pancreatectomy and Open distal pancreatectomy in people with Pancreatic Cancer and Surgery, run by Fudan University at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianjun Yu, M.D., Ph.D. (+86-21-64175590 ext. 1307, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03792932, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.