Clinical trial · Interventional
Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer
A Multicenter Prospective RCT Study of Laparoscopic Versus Open Distal Pancreatectomy in Patients With Pancreatic Cancer at the Body and Tail
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laparoscopy | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic distal pancreatectomy | Procedure | — | UNRESOLVED |
| Open distal pancreatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic distal pancreatectomy
- interventionNames
- Procedure: Laparoscopic distal pancreatectomy
- type
- ACTIVE_COMPARATOR
- label
- Open distal pancreatectomy
- interventionNames
- Procedure: Open distal pancreatectomy
Primary outcomes (1)
- measure
- Recurrence Free Survival
- timeFrame
- 2 years
- description
- RFS
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 19 years and ≤ 80 years, no gender limitation 2. Resectable body and tail pancreatic cancer (refer to NCCN 2018) 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4. Tumor locates at the body and tail of the pancreas without distant metastasis 5. No celiac trunk and superior mesenteric artery invasion 6. No operation contraindication, fit for laparoscopic surgery 7. The expected survival after surgery ≥ 3 months 8. Patients who are willing and able to comply with the study procedure 9. Signed informed content obtained prior to treatment Exclusion Criteria: 1. Locally advanced unresectable body and tail pancreatic cancer 2. Multi-organ and vascular resection needed 3. Patients undergoing total pancreatectomy 4. Benign tumor at the body and tail of the pancreas or pancreatic cancer at the head of the pancreas 5. Distant metastasis or ascites detected by imaging 6. Severe important organ function impairment (heart, liver, kidney) 7. Patients who are with other primary malignancy or haematological disorders 8. Pregnant or nursing women 9. Patients who have received chemotherapy, radiotherapy and interventional therapy before the pancreatectomy 10. Patients who have participated in other clinical trials for pancreatic cancer treatment within 3 months
References
Publications (5)
- BACKGROUNDRicci 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. PMID 25560180
- BACKGROUNDvan 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. PMID 29099399
- BACKGROUNDSulpice 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. PMID 26583678
- BACKGROUNDShin 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. PMID 25529901